FDA 510(k) Applications for Medical Device:
Tester, Auditory Impedance
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K983049 | AMERICAN ELECTROMEDICS CORP. |
P.O. BOX 9169 | CHICO | CA | 95927 |
| K983051 | AMERICAN ELECTROMEDICS CORP. |
P.O. BOX 9169 | CHICO | CA | 95927 |
| K983046 | AMERICAN ELECTROMEDICS CORP. |
P.O. BOX 9169 | CHICO | CA | 95927 |
| K031978 | AMPLAID |
PO BOX 7007 | DEERFIELD | IL | 60015 |
| K992370 | AMPLIFON S.P.A. |
P.O. BOX 7007 | DEERFIELD | IL | 60015 |
| K974235 | AMPLIFON S.P.A. |
P.O. BOX 7007 | DEERFIELD | IL | 60015 |
| K081841 | AMPLIVOX, LTD. |
P.O. BOX 7007 | DEERFIELD | IL | 60015 |
| K171038 | dB Diagnostic Systems, Inc. |
17 Sachem Road | Weston | CT | 06883 |
| K183201 | dB Diagnostic Systems, Inc. |
17 Sachem Road | Weston | CT | 06883 |
| K151509 | Diagnostic Group, dba Grason-Stadler |
7625 Golden Triangle Drive, Suite F | Eden Prairie | MN | 55344 |
| K161707 | GN OTOMETRICS |
Hoerskaetten 9 | Taatrup | DK-2630 | |
| K033645 | GN OTOMETRICS A/S |
DYBENDALSVAENGET 2 | TAASTRUP | DK-2630 | |
| K000097 | GRASON-STADLER, INC. |
1 WESTCHESTER DR. | MILFORD | NH | 03055-3056 |
| K990585 | IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) |
4814 EAST SECOND ST. | BENICIA | CA | 94510 |
| K990652 | IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) |
4814 EAST SECOND ST. | BENICIA | CA | 94510 |
| K983832 | IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) |
4814 EAST SECOND ST. | BENICIA | CA | 94510 |
| K070312 | INNOVIA MEDICAL, LLC |
13 RED FOX LANE | LITTLETON | CO | 80127 |
| K151616 | INTERACOUSTICS A/S |
DREJERVAENGET 8 | ASSENS | DK-5610 | |
| K121847 | INTERACOUSTICS A/S |
DREJERVAENGET 8 | ASSENS | DK-5610 | |
| K022728 | INTERACOUSTICS A/S, ASSENS |
9675 WEST 76TH ST. | EDEN PRAIRIE | MN | 55344 |
| K083861 | INTERACOUSTICS AS |
DREJERVAENGET 8 | ASSENS | DK-5610 | |
| K994254 | INTERNATIONAL DISTRIBUTORS OF ELECTRONICS FOR MEDI |
4814 EAST SECOND ST. | BENICIA | CA | 94510 |
| K133013 | INVENTIS SRL |
CORSO STATI UNITI 1/3 | PADOVA | 35127 | |
| K162210 | MAICO DIAGNOSTICS GMBH |
SICKINGENSTR. 70-71 | BERLIN | 10553 | |
| K971859 | MDI INSTRUMENTS, INC. |
200 UNICORE PARK DR. | WOBURN | MA | 01801 |
| K970685 | MDI INSTRUMENTS, INC. |
200 UNICORE PARK DR. | WOBURN | MA | 01801 |
| K991562 | PASCAL MEDICAL AB |
7307 GLOUCHESTER DR. | MINNEAPOLIS | MN | 55435 |
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