FDA 510(k) Applications for Medical Device:
Standard Polysomnograph With Electroencephalograph
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K992283 | AIRSEP CORP. |
290 CREEKSIDE DR. | BUFFALO | NY | 14228 |
| K001013 | AIRSEP CORP. |
290 CREEKSIDE DR. | BUFFALO | NY | 14228 |
| K050425 | ASTRO-MED, INC. |
600 EAST GREENWICH AVE. | WEST WARWICK | RI | 02893 |
| K970951 | ASTRO-MED, INC. |
600 EAST GREENWICH AVE. | WEST WARWICK | RI | 02893 |
| K003681 | BIO-LOGIC SYSTEMS CORP. |
ONE BIO-LOGIC PLAZA | MUNDELEIN | IL | 60060-3700 |
| K052066 | BIO-LOGIC SYSTEMS CORP. |
ONE BIO-LOGIC PLAZA | MUNDELEIN | IL | 60060-3700 |
| K983913 | BIO-LOGIC SYSTEMS CORP. |
ONE BIO-LOGIC PLAZA | MUNDELEIN | IL | 60060-3700 |
| K984580 | BIOSYS AB (PUBL) |
485 LAROE RD. | CHESTER | NY | 10918 |
| K991446 | BIOSYS AB (PUBL) |
485 LAROE RD. | CHESTER | NY | 10918 |
| K031202 | BRAEBON MEDICAL CORP. |
120 WALGREEN DR (RR#3) | CARP, ONTARIO | K0A 1L0 | |
| K192624 | Cadwell Industries, Inc. |
909 N. Kellogg Street | Kennewick | WA | 99336 |
| K213007 | Cerebra Medical Ltd. |
1470 Wilson Place | Winnipeg | R3T2N9 | |
| K042039 | CLEVELAND MEDICAL DEVICES, INC. |
4415 EUCLID AVE | CLEVELAND | OH | 44103 |
| K003175 | COMPUMEDICS LIMITED |
6740 RIVERVIEW TERRACE | MINNEAPOLIS, | MN | 55432 |
| K242447 | Compumedics Limited |
30-40 Flockhart St | Abbotsford | 3067 | |
| K101830 | CONSOLIDATED RESEARCH OF RICHMOND, INC |
26250 EUCLID AVE | EUCLID | OH | 44132 |
| K172986 | Consolidated Research of Richmond, Inc. dba General Sleep Co |
26250 Euclid Avenue, Suite 709 | Cleveland | OH | 44132 |
| K093728 | EB NEURO, S.P.A. |
11460 N. MERIDIAN ST. | CARMEL | IN | 46032 |
| K991900 | EXCEL TECH. LTD. |
2892 PORTLAND DR. | OAKVILLE,ONTARIO | L6H 5W8 | |
| K022037 | EXCEL TECH. LTD. |
2568 BRISTOL CIRCLE | OAKVILLE, ONTARIO | L6H 5S1 | |
| K971813 | FERGUSON MEDICAL |
3407 BAY AVE. | CHICO | CA | 95973-8619 |
| K994142 | GRASS INSTRUMENT CO. |
570 LIBERTY ST. | BRAINTREE | MA | 02185 |
| K021807 | GRASS INSTRUMENT CO. |
570 LIBERTY ST. | BRAINTREE | MA | 02185 |
| K012976 | GRASS-TELEFACTOR DIVISON |
| WEST-WARWICK | RI | 02893 |
| K974583 | GRASS-TELEFACTOR PRODUCT GROUP |
1094 NEW DEHAVEN AVE. | WEST CONSHOHOCKEN | PA | 19428 |
| K992291 | GRASS-TELEFACTOR PRODUCT GROUP |
1094 NEW DEHAVEN AVE. | WEST CONSHOHOCKEN | PA | 19428 |
| K974587 | GRASS-TELEFACTOR PRODUCT GROUP |
1094 NEW DEHAVEN AVE. | WEST CONSHOHOCKEN | PA | 19428 |
| K971867 | HEALTHDYNE TECHNOLOGIES, INC. |
1850 PARKWAY PLACE | MARIETTA | GA | 30067 |
| K990522 | LA MONT MEDICAL, INC. |
555 D'ONOFRIO DR. | MADISON | WI | 53719-2053 |
| K042364 | LAMONT MEDICAL INC |
800 LEVANGER LANE | STOUGHTON | WI | 53589 |
| K010460 | LIFELINES LTD. |
PO BOX 4341 | CROFTON | MD | 21114 |
| K050143 | MAYS AND ASSOCIATES, INC. |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071-3404 |
| K071782 | MICROMED S.P.A. |
VIA GIOTTO 2 | MOGLIANO VENETO (TV) | 31021 | |
| K172711 | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) |
2568 Bristol Circle | Oakville | L6H 5S1 | |
| K173690 | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) |
2568 Bristol Circle | Oakville | L6H 5S1 | |
| K131415 | NEUROTRONICS, INC. |
3600 NW 43RD ST, STE F1 | Gainesville | FL | 32606 |
| K142774 | Neurotronics, Inc. |
3600 NW 43rd Street, Suite F1 | Gainesville | FL | 32606 |
| K161650 | Neurotronics, Inc. |
3600 NW 43rd Street, STE F1 | Gainesville | FL | 32606 |
| K173868 | Neurotronics, Inc. |
4500 NW 27th Ave Ste C2 | Gainesville | FL | 32606 |
| K181709 | Neurotronics, Inc. |
4500 NW 27th Ave Ste C2 | Gainesville | FL | 32606 |
| K983072 | NIHON KOHDEN AMERICA, INC. |
2601 CAMPUS DR. | IRVINE | CA | 92612-1601 |
| K073491 | NIHON KOHDEN AMERICA, INC. |
90 ICON ST. | FOOTHILL RANCH | CA | 92610-1601 |
| K050833 | NIHON KOHDEN AMERICA, INC. |
90 ICON ST. | FOOTHILL RANCH | CA | 92610-1601 |
| K992742 | NIHON KOHDEN AMERICA, INC. |
2601 CAMPUS DR. | IRVINE | CA | 92612-1601 |
| K011204 | NIHON KOHDEN AMERICA, INC. |
90 ICON ST. | FOOTHILL RANCH | CA | 92610-1601 |
| K022121 | NIHON KOHDEN AMERICA, INC. |
90 ICON ST. | FOOTHILL RANCH | CA | 92610-1601 |
| K000338 | NIHON KOHDEN AMERICA, INC. |
2601 CAMPUS DR. | IRVINE | CA | 92612-1601 |
| K033475 | NIHON KOHDEN AMERICA, INC. |
90 ICON ST. | FOOTHILL RANCH | CA | 92610-1601 |
| K241288 | Nox Medical ehf |
Katrinartuni 2 | Reykjavik | ||
| K961638 | OXFORD INSTRUMENTS MEDICAL SYSTEMS |
11526 53ND ST. N | CLEARWATER | FL | 34620 |
| K111055 | PERSONAL HEALTH INSTITUTE INTERNATIONAL |
263 CEDAR CREEK DRIVE | BATTLE CREEK | MI | 49015 |
| K012085 | SENSORMEDICS CORP. |
22705 SAVI RANCH PKWY. | YORBA LINDA | CA | 92887-4645 |
| K240700 | Somnomedics GMBH |
Am Sonnenstuhl 63 | Randersacker | 97236 | |
| K201054 | Somnomedics GmbH |
Am Sonnenstuhl 63 | Randersacker | 97236 | |
| K010728 | STELLATE SYSTEMS |
345 VICTORIA AVE., SUITE 300 | WESTMOUNT, QUEBEC | H3Z 2N2 | |
| K013450 | STELLATE SYSTEMS |
345 VICTORIA AVE., SUITE 300 | WESTMOUNT, QUEBEC | H3Z 2N2 | |
| K021185 | TAUGAGREINING HF |
PO BOX 4341 | CROFTON | MD | 21114 |
| K022249 | TELEDIAGNOSTIC SYSTEMS, INC. |
1757 EAST BAYSHORE RD., #24 | REDWOOD CITY | CA | 94063-4151 |
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