FDA 510(k) Applications for Medical Device:
Electromyograph, Diagnostic
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K973355 | ADVANTAGE MEDICAL DIVISION OF CME TELEMETRIX |
100 COLLIP CIRCLE, #100 | LONDON | N6G 4X8 | |
| K974010 | ADVANTAGE MEDICAL DIVISION OF CME TELEMETRIX |
100 COLLIP CIRCLE, #100 | LONDON | N6G 4X8 | |
| K023147 | BORTEC BIOMEDICAL, LTD. |
936-11TH AVENUE EAST | SEATTLE | WA | 98102 |
| K162383 | CADWELL INDUSTRIES, INC. |
909 NORTH KELLOGG STREET | KENNEWICK | WA | 99336 |
| K131094 | DORSA VI PTY. LTD |
1914 J N PEASE PLACE | CHARLOTTE | NC | 28262 |
| K163150 | DORSAVI LTD |
LEVEL 1, 120 JOLIMONT RD | EAST MELBOURNE | 3002 | |
| K142494 | dorsaVi Ltd. |
Level 1, 120 Jolimont Road | East Melbourne | 3002 | |
| K073415 | EB NEURO, S.P.A. |
11460 N. MERIDIAN ST. | CARMEL | IN | 46032 |
| K972419 | ERICH JAEGER, INC. |
LEIBNIZSTRABE 7 | HOECHBERG, GERMANY | ||
| K052112 | EXCEL TECH. LTD. |
2568 BRISTOL CIRCLE | OAKVILLE, ONTARIO | L6H 5S1 | |
| K033452 | FASSTECH |
76 TREBLE COVE RD. | NORTH BILLERICA | MA | 01862 |
| K063447 | FASSTECH |
76 TREBLE COVE RD. | NORTH BILLERICA | MA | 01862 |
| K023209 | FASSTECH |
76 TREBLE COVE RD. | NORTH BILLERICA | MA | 01862 |
| K993878 | JACK'S ELECTRODES |
2227 EAST CRESCENT DR. | ALTADENA | CA | 91001 |
| K002104 | MARYROSE CUSIMANO, PH.D. & SCOTT ZEFF |
7481 W. OAKLAND PARK BLVD. | FT. LAUDERDALE | FL | 33319 |
| K022719 | MARYROSE CUSIMANO, PH.D./PHIL REASTON |
5367 NW 90TH AVE. | SUNRISE | FL | 33319 |
| K031995 | MEDICAL TECHNOLOGIES UNLIMITED, INC. |
7538 BEAR CANYON RD. NE | ALBUQUERQUE | NM | 87109 |
| K113074 | MEDICAL TECHNOLOGIES, INC. |
5901-J WYOMING NE, | ALBUQUERQUE | NM | 87106 |
| K024316 | MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216 |
| K000220 | MOTION LAB SYSTEMS, INC. |
4326 PINE PARK DR. | BATON ROUGE | LA | 70809-2397 |
| K974385 | MOTION LAB SYSTEMS, INC. |
4326 PINE PARK DR. | BATON ROUGE | LA | 70809-2397 |
| K172743 | Natus Neurology Incorporated |
3150 Pleasant View Road | Middleteon | WI | 53562 |
| K001562 | NEURO SCAN LABS |
5700 CROMO DR., SUITE 100 | EL PASO | TX | 79912-5538 |
| K000812 | NEUROSOFT, INC. |
5700 CROMO DR. | EL PASO | TX | 79912 |
| K010590 | NIHON KOHDEN AMERICA, INC. |
90 ICON ST. | FOOTHILL RANCH | CA | 92610-1601 |
| K123902 | OKTX LLC |
7225 S 85TH E AVE. | TULSA | OK | 74137 |
| K984052 | OXFORD INSTRUMENTS MEDICAL SYSTEMS |
P.O. BOX 4341 | CROFTON | MD | 21114 |
| K990766 | PARASPINAL DIAGNOSTIC CORP. |
11605 HITCHING POST LN. | ROCKVILLE | MD | 20852 |
| K123399 | PRECISION BIOMETRICS, INC. |
2303 W Commodore Way Ste 301 | Seattle | WA | 98199 |
| K001800 | RJL ASSOCIATES, LLC. |
86-3 BOSTON POST RD. | WATERFORD | CT | 06385 |
| K110048 | SPINEMATRIX, INC. |
1835 MARKET STREET | PHILADELPHIA | PA | 19103 |
| K102610 | TELEEMG, LLC USA |
65 ARLINGTON ROAD | WOBURN | MA | 01801 |
| K083679 | UROVAL |
5353 WAYZATA BLVD. | MINNEAPOLIS | MN | 55416 |
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