FDA 510(k) Applications for Medical Device:
Electroencephalograph
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K131383 | ADVANCED BRAIN MONITORING INC. |
W324 S3649 COUNTY ROAD E | DOUSMAN | WI | 53118 |
| K033978 | ASTRO-MED, INC. |
600 EAST GREENWICH AVE. | WEST WARWICK | RI | 02893 |
| K022785 | AXON SYSTEMS, INC. |
400-2200 OSER AVE. | HAUPPAUGE | NY | 11788 |
| K002316 | AXON SYSTEMS, INC. |
400-2200 OSER AVE. | HAUPPAUGE | NY | 11788 |
| K010697 | AXON SYSTEMS, INC. |
400-2200 OSER AVE. | HAUPPAUGE | NY | 11788 |
| K973883 | BIO-LOGIC SYSTEMS CORP. |
ONE BIO-LOGIC PLAZA | MUNDELEIN | IL | 60060-3700 |
| K002570 | BIO-LOGIC SYSTEMS CORP. |
ONE BIO-LOGIC PLAZA | MUNDELEIN | IL | 60060-3700 |
| K954954 | BIO-LOGIC SYSTEMS CORP. |
ONE BIO-LOGIC PLAZA | MUNDELEIN | IL | 60060-3700 |
| K112817 | BIO-SIGNAL GROUP CORPORATION |
760 PARKSIDE AVE | BROOKLYN | NY | 11226 |
| K170138 | BIOSERENITY |
47 boulevard de l'Hopital | Paris | 75013 | |
| K223644 | Bioserenity |
47 Boulevard De L Hopital ICM-IPEPS - | Paris | 75013 | |
| K202334 | Bioserenity SAS |
ICM-iPEPS, 47 Boulevard de l'Hopital | Paris | 75013 | |
| K970703 | BIOSOUND ESAOTE, INC. |
8000 CASTLEWAY DR. | INDIANAPOLIS | IN | 46250 |
| K122196 | BLACKROCK NEUROMED, LLC |
117 WEST SOUTH STREET | OCONOMOWOC | WI | 53066 |
| K150498 | BRAINMASTER TECHNOLOGIES, INC. |
195 Willis Street, Suite 3 | Bedford | OH | 44146 |
| K180269 | Cadwell Industries, Inc. |
909 North Kellogg Street | Kennewick | WA | 99336 |
| K201819 | Cadwell Industries, Inc. |
909 North Kellogg Street | Kennewick | WA | 99336 |
| K133355 | CADWELL INDUSTRIES, INC. |
909 N Kellogg St | KENNEWICK | WA | 99336 |
| K181466 | Cadwell Industries, Inc. |
909 North Kellogg Street | Kennewick | WA | 99336 |
| K093223 | COMPUMEDICS LIMITED |
30-40 FLOCKHART STREET | ABBOTSFORD, VICTORIA | 3067 | |
| K230073 | Compumedics Limited |
30-40 Flockhart Street | Abbotsford | 3067 | |
| K081151 | COMPUMEDICS USA, LTD. |
6605 WEST WT HARRIS BLVD | CHARLOTTE | NC | 28269 |
| K193159 | Corscience gmbH & Co. KG |
Hartmannstrasse 65 | Erlangen | 91052 | |
| K971329 | CTF SYSTEMS, INC. |
15-1750 MCLEAN AVE. | PORT COQUITLAM, B.C. | V3C 1M9 | |
| K221963 | Cumulus Neuroscience Limited |
The Innovation Center, Unit 4, Queens Road | Belfast | BT3 9DT | |
| K042626 | CYBERKINETICS, INC. |
100 FOXBORO BLVD. SUITE 240 | FOXBORO | MA | 02035 |
| K051825 | EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH |
PO BOX 7007 | DEERFIELD | IL | 60015 |
| K112353 | ELECTRICAL GEODESICS, INC. |
29611 SIMMONS ROAD | EUGENE | OR | 97405 |
| K033399 | ELECTRICAL GEODESICS, INCORPORATED |
1630 DUTCH RAVINE COURT | RENO | NV | 89521-5160 |
| K012079 | ELECTRICAL GEODESICS, INCORPORATED |
3636 E. COLUNBINE DR. | PHOENIX | AZ | 85032-7372 |
| K043309 | ELECTRICAL GEODESICS, INCORPORATED |
29611 SIMMONS ROAD | EUGENE | OR | 97405 |
| K171781 | Evoke Neuroscience, Inc. |
200 Valencia Dr. | Jacksonville | NC | 28546 |
| K000919 | EXCEL TECH. LTD. |
2568 BRISTOL CIRCLE | OAKVILLE, ONTARIO | L6H 5S1 | |
| K010150 | EXCEL TECH. LTD. |
2568 BRISTOL CIRCLE | OAKVILLE, ONTARIO | L6H 5S1 | |
| K021599 | EXCEL TECH. LTD. |
2568 BRISTOL CIRCLE | OAKVILLE, ONTARIO | L6H 5S1 | |
| K000898 | EXCEL TECH. LTD. |
2568 BRISTOL CIRCLE | OAKVILLE, ONTARIO | L6H 5S1 | |
| K010091 | EXCEL TECH. LTD. |
2568 BRISTOL CIRCLE | OAKVILLE, ONTARIO | L6H 5S1 | |
| K040360 | EXCEL TECH. LTD. |
2568 BRISTOL CIRCLE RD. | OAKVILLE, ONTARIO | L6H 5S1 | |
| K982479 | EXCEL TECH. LTD. |
2892 PORTLAND DR. | OAKVILLE,ONTARIO | L6H 5W8 | |
| K980214 | EXCEL TECH. LTD. |
2892 PORTLAND DR. | OAKVILLE,ONTARIO | L6H 5W8 | |
| K010088 | EXCEL TECH. LTD. |
2568 BRISTOL CIRCLE | OAKVILLE, ONTARIO | L6H 5S1 | |
| K010086 | EXCEL TECH. LTD. |
2568 BRISTOL CIRCLE | OAKVILLE, ONTARIO | L6H 5S1 | |
| K010084 | EXCEL TECH. LTD. |
2568 BRISTOL CIRCLE | OAKVILLE, ONTARIO | L6H 5S1 | |
| K010089 | EXCEL TECH. LTD. |
2568 BRISTOL CIRCLE | OAKVILLE, ONTARIO | L6H 5S1 | |
| K001103 | EXCEL TECH. LTD. |
2568 BRISTOL CIRCLE | OAKVILLE, ONTARIO | L6H 5S1 | |
| K053386 | EXCEL TECH. LTD. |
2568 BRISTOL CIRCLE | OAKVILLE, ONTARIO | L6H 5S1 | |
| K042150 | EXCEL TECH. LTD. |
2568 BRISTOL CIRCLE | OAKVILLE, ONTARIO | L6H 5S1 | |
| K081741 | EXCEL-TECH LTD. (XLTEK) |
2568 BRISTOL CIR. | OAKVILLE, ONTARIO | L6H 5S1 | |
| K131266 | EXCEL-TECH LTD. (XLTEK) |
2568 BRISTOL CIR. | OAKVILLE, ONTARIO | L6H 5S1 | |
| K103129 | GE HEALTHCARE |
86 PILGRIM ROAD | NEEDHAM | MA | 02492 |
| K972202 | GRASS-TELEFACTOR PRODUCT GROUP |
1094 NEW DEHAVEN AVE. | WEST CONSHOHOCKEN | PA | 19428 |
| K191868 | iCE Neurosystems, Inc. |
1875 Connecticut Ave NW, Suite 12117 | Washington | DC | 20007 |
| K220056 | iMediSync Inc. |
3rd FL. 175 Yeoksam-ro, Gangnam-gu | Seoul | 06247 | |
| K992410 | INDIVIDUAL MONITORING SYSTEMS, INC. |
1055 TAYLOR AVE., SUITE 300 | BALTIMORE | MD | 21286-8334 |
| K010997 | INDIVIDUAL MONITORING SYSTEMS, INC. |
1055 TAYLOR AVE., SUITE 300 | BALTIMORE | MD | 21286-8334 |
| K101386 | INFINITE BIOMEDICAL TECHNOLOGIES, LLC |
3600 CLIPPER MILL ROAD | BALTIMORE | MD | 21211 |
| K172271 | Lifelines Ltd. |
7 Clarendon Court | Over Wallop | SO20 8HU | |
| K040554 | MANUFACTURING TECHNOLOGY, INC. |
70 READY AVE., N.W. | FORT WALTON BEACH | FL | 32548 |
| K192753 | Medeia, Inc. |
7 W Figueroa Street, Suites 300 | Santa Barbara | CA | 93101 |
| K964280 | MEDELEC LTD. |
MANOR WAY | OLD WOKING, SURREY | GU22 9JU | |
| K173460 | MemoryMD Inc. |
205 East 42nd St 14th FL | New York | NY | 10017 |
| K171384 | Micromed S.P.A |
Via Giotto 2 | Mogliano Veneto | 31021 | |
| K011430 | MINI-MITTER CO., INC. |
20300 EMPIRE AVE. BLDG. B-3 | BEND | OR | 97701 |
| K983533 | MINI-MITTER CO., INC. |
PO BOX 3386 | SUNRIVER | OR | 97707 |
| K991033 | MINI-MITTER CO., INC. |
PO BOX 3386 | SUNRIVER | OR | 97707 |
| K143233 | MITSAR CO., LTD |
Novorossiyskaya str. 21-2 | St. Petersburg | 194021 | |
| K170441 | MobileMedTek |
1205 E. Washington St., Ste 115 | Louisville | KY | 40206 |
| K143440 | NATUS MEDICAL INCORPORATED |
DBA EXCEL-TECH LTD (XLTEK) | OAKVILLE | L6H 5S1 | |
| K100683 | NATUS MEDICAL INCORPORATED |
DBA EXCEL-TECH LTD (XLTEK) | OAKVILLE, ONTARIO | L6H 5S1 | |
| K180181 | Natus Medical Incorporated DBA Excel_tech Ltd. (XLTEK) |
2568 Bristol Circle | Oakville | L6H 5S1 | |
| K180290 | Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) |
2568 Bristol Circle | Oakville | L6H 5S1 | |
| K162595 | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) |
2568 Bristol Circle | Oakville | L6H 5S1 | |
| K163163 | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) |
2568 Bristol Circle | Oakville | L6H 5S1 | |
| K974495 | NEUROCORP, LTD. |
150 WHITE PLAINS RD. | TARRYTOWN | NY | 10591 |
| K162681 | Neuroelectrics Barcelona S.L.U. |
Avenida Tibidabo 47 bis | Barcelona | 08035 | |
| K221959 | NeuroField Inc. |
386 West Lane | Bishop | CA | 93514 |
| K023771 | NEUROSCAN |
7850 PASEO DEL NORTE | EL PASO | TX | 79912 |
| K112107 | NEUROVIRTUAL USA, INC. |
2315 NW 107TH AVE | DORAL | FL | 33172 |
| K131335 | NEUROVIRTUAL USA, INC. |
2315 NW 107TH AVE STE 1M27 | DORAL | FL | 33172 |
| K191492 | Neurovirtual USA, INC. |
3303 W Commercial Blvd #100 | Fort Lauderdale | FL | 33309 |
| K991054 | NICOLET BIOMEDICAL, INC. |
5225 VERONA RD. | MADISON | WI | 53711 |
| K971331 | NICOLET BIOMEDICAL, INC. |
5225 VERONA RD. | MADISON | WI | 53711 |
| K113117 | NIHON KOHDEN AMERICA, INC. |
90 ICON ST. | FOOTHILL RANCH | CA | 92610-1601 |
| K110376 | NIHON KOHDEN CORP. |
90 ICON STREET | FOOTHILL RANCH | CA | 92610 |
| K120888 | NIHON KOHDEN CORP. |
90 ICON STREET | FOOTHILL RANCH | CA | 92610 |
| K171124 | Nihon Kohden Corporation |
1-31-4 Nisahiochiai, Shinjuku-Ku | Tokyo | 161-8560 | |
| K961642 | OXFORD INSTRUMENTS, PLC. |
11526 53RD ST. N. | CLEARWATER | FL | 34620 |
| K962447 | PHYSIOMETRIX, INC. |
FIVE BILLERICA PARK, | NORTH BILLERICA | MA | 01862 |
| K962157 | PHYSIOMETRIX, INC. |
FIVE BILLERICA PARK, | NORTH BILLERICA | MA | 01862 |
| K970942 | PHYSIOMETRIX, INC. |
FIVE BILLERICA PARK, | NORTH BILLERICA | MA | 01862 |
| K071109 | SACS MEDICAL AB |
3684 NORTH SHASTA LOOP | EUGENE | OR | 97405 |
| K212788 | Seer Medical Pty Ltd |
| Melbourne | 3133 | |
| K231457 | SPARK Neuro Inc. |
212 West 18th Street, Unit 17A | New York | NY | 10011 |
| K083577 | STELLATE SYSTEMS |
376 VICTORIA AVENUE, SUITE 200 | MONTREAL, QUEBEC | H3Z 1C3 | |
| K010669 | THURIS CORP. |
110 GLENN WAY # 6 | SAN CARLOS | CA | 94070 |
| K061908 | VIASYS NEUROCARE |
800 LEVANGER LANE | STOUGHTON | WI | 53589 |
| K213900 | WAVi Co. |
3459 Ringsby Ct. Ste. #305 | Denver | CO | 80216 |
| K014147 | XLTEK |
2568 BRISTOL CIRCLE | OAKVILLE | L6H 5S1 | |
| K014146 | XLTEK |
2568 BRISTOL CIRCLE | OAKVILLE | L6H 5S1 | |
| K172735 | Zeto, Inc. |
2336 Park Ave | Santa Clara | CA | 95050 |
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