FDA 510(k) Applications for Medical Device:
Electrode, Needle, Diagnostic Electromyograph
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K093825 | AMBU A/S |
6740 BAYMEADOW DR. | GLEN BURNIE | MD | 21060 |
| K071186 | AMBU A/S |
6740 BAYMEADOW DR. | GLEN BURNIE | MD | 21060 |
| K152984 | BIO PROTECH, INC. |
DONGHWA MEDICAL INSTRUMENT COMPLEX, 151-3, | WONJU-SI | 220-801 | |
| K092973 | BIONEN S.A.S. |
11460 N. MERIDIAN ST., STE 150 | CARMEL | IN | 46032 |
| K111131 | CAREFUSION 209, INC. |
1850 Deming Way | Middleton | WI | 53562 |
| K112034 | CAREFUSION 209, INC. |
1850 Deming Way | Middleton | WI | 53562 |
| K955335 | CHALGREN ENTERPRISES, INC. |
8021 CARMEL ST. | GILROY | CA | 95020 |
| K982950 | CHALGREN ENTERPRISES, INC. |
8021 CARMEL ST. | GILROY | CA | 95020 |
| K960591 | CHALGREN ENTERPRISES, INC. |
8021 CARMEL ST. | GILROY | CA | 95020 |
| K961013 | MEDELEC INTL. CORP. |
MANOR WAY | ENGLAND | ||
| K973442 | MEDELEC, INC. D.B.A. TECA CORP. |
3 CAMPUS DR. | PLEASANTVILLE | NY | 10570 |
| K973444 | MEDELEC, INC. D.B.A. TECA CORP. |
3 CAMPUS DR. | PLEASANTVILLE | NY | 10570 |
| K001869 | MEDICOTEST A/S |
1900 K ST. N.W. | WASHINGTON | DC | 20006-1108 |
| K973529 | MEDICOTEST A/S |
1900 K ST. N.W. | WASHINGTON | DC | 20006-1108 |
| K020907 | MEDICOTEST A/S |
1800 MASSCHUSETTS AVE., N.W. | WASHINGTON | DC | 20036-1221 |
| K002992 | MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
16-18 TONSBAKKEN | SKOVLUNDE | DK-2740 | |
| K990375 | MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
TONSBAKKEN 16-18 | COPENHAGEN | DK-2740 | |
| K173815 | Natus Manufacturing Limited |
IDA Business Park | Gort | H91 PD92 | |
| K143433 | Natus Manufacturing Limited |
IDA Business Park | Gort | ||
| K161430 | Natus Manufacturing Limited |
IDA Business Park | Gort | ||
| K011818 | NICOLET BIOMEDICAL, INC. |
800 LEVANGER LN. | STOUGHTON | WI | 53589 |
| K120342 | RHYTHMLINK INTERNATIONAL, LLC |
1140 FIRST ST. SOUTH | COLUMBIA | SC | 29209 |
| K091055 | RHYTHMLINK INTERNATIONAL, LLC |
1256 FIRST ST. SOUTH EXTENSION | COLUMBIA | SC | 29209 |
| K091056 | RHYTHMLINK INTERNATIONAL, LLC |
1256 FIRST ST. SOUTH EXTENSION | COLUMBIA | SC | 29209 |
| K080914 | ROCHESTER ELECTRO MEDICAL, INC. |
4212 CYPRESS GULCH DRIVE | LUTZ | FL | 33559 |
| K981004 | SPECIALIZED LABORATORY EQUIPMENT, LTD. |
3407 BAY AVE. | CHICO | CA | 95973 |
| K091410 | SPES MEDICA S.R.L. |
VIA EUROPA-ZONA INDUSTRIALE | BATTIPAGLIA | 84091 | |
| K062437 | TECHNOMED EUROPE |
AMERIKALAAN 71 | MAASTRICHT AIRPORT | 6199 AE | |
| K990015 | TECHNOMED EUROPE |
STATIONSTRAAT 122 | 6191 BG BEEK | 6191 BG |
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