FDA 510(k) Applications for Medical Device:
Stimulator, Auditory, Evoked Response
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K021215 | BIO-LOGIC SYSTEMS CORP. |
ONE BIO-LOGIC PLAZA | MUNDELEIN | IL | 60060-3700 |
| K992807 | BIO-LOGIC SYSTEMS CORP. |
ONE BIO-LOGIC PLAZA | MUNDELEIN | IL | 60060-3700 |
| K021895 | BIO-LOGIC SYSTEMS CORP. |
ONE BIO-LOGIC PLAZA | MUNDELEIN | IL | 60060-3700 |
| K073626 | BIO-LOGIC SYSTEMS CORP. |
ONE BIOLOGIC PLAZA | MUNDELEIN | IL | 60060 |
| K031009 | BIO-LOGIC SYSTEMS CORP. |
ONE BIO-LOGIC PLAZA | MUNDELEIN | IL | 60060-3700 |
| K994149 | BIO-LOGIC SYSTEMS CORP. |
ONE BIO-LOGIC PLAZA | MUNDELEIN | IL | 60060-3700 |
| K030907 | BIO-LOGIC SYSTEMS CORP. |
ONE BIO-LOGIC PLAZA | MUNDELEIN | IL | 60060-3700 |
| K972157 | EXCEL TECH. LTD. |
2892 PORTLAND DR. | OAKVILLE,ONTARIO | L6H 5W8 | |
| K013977 | FISCHER-ZOTH AUDIOLOGIC SYSTEMS, INC. |
1257 WEST MARGARET VIEW CIRCLE | RIVERTON | UT | 84065 |
| K123701 | FRYE ELECTRONICS, INC. |
9826 S.W. TIGARD ST. | TIGARD | OR | 97223 |
| K092373 | GN OTOMETRICS |
333 MILFORD RD | DEERFIELD | IL | 60015 |
| K132957 | GN OTOMETRICS |
8870 RAVELLO CT | NAPLES | FL | 34114 |
| K122067 | GN OTOMETRICS |
HOERSKAETTEN 9 | TAATRUP | DK-2630 | |
| K083399 | GN OTOMETRICS A/S |
125 COMMERCE DRIVE | SCHAUMBURG | IL | 60173-5329 |
| K143670 | GN OTOMETRICS A/S |
HOERSKAETTEN 9 | TAASTRUP REGION HOVEDSTADEN | DK-2630 | |
| K193033 | Grason Stadler |
10395 West 70th Street | Eden Prairie | MN | 55344 |
| K960097 | ICS MEDICAL CORP. |
2227 HAMMOND DR. | SCHAUMBURG | IL | 60173-3860 |
| K002985 | ICS MEDICAL CORP. |
125 COMMERCE DR. | SCHAUMBURG | IL | 60173-5329 |
| K991853 | IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) |
4814 EAST SECOND ST. | BENICIA | CA | 94510 |
| K073384 | INTELLIGENT HEARING SYSTEMS |
6860 S.W. 81ST ST. | MIAMI | FL | 33143 |
| K061443 | INTELLIGENT HEARING SYSTEMS |
6860 S.W. 81ST ST. | MIAMI | FL | 33143 |
| K163326 | INTELLIGENT HEARING SYSTEMS |
6860 SW 81ST st Street | MIAMI | FL | 33143 |
| K031051 | INTELLIGENT HEARING SYSTEMS |
7356 S.W. 48 ST. | MIAMI | FL | 33155 |
| K070608 | INTELLIGENT HEARING SYSTEMS |
6860 S.W. 81ST ST. | MIAMI | FL | 33143 |
| K090579 | INTELLIGENT HEARING SYSTEMS |
6860 S.W. 81ST ST. | MIAMI | FL | 33143 |
| K162037 | INTERACOUSTICS A/S |
AUDIOMETER ALLE 1 | Middelfart | 5500 | |
| K070696 | INTERACOUSTICS A/S |
7625 GOLDEN TRIANGLE DRIVE | EDEN PRAIRIE | MN | 55344 |
| K103760 | INTERACOUSTICS A/S |
DREJERVAENGET 8 | ASSENS | DK-5610 | |
| K011746 | MAICO DIAGNOSTIC GMBH |
9675 WEST 76TH ST. | EDEN PRAIRIE | MN | 55344 |
| K082035 | MAICO DIAGNOSTICS |
7625 GOLDEN TRIANGLE DR. | EDEN PRAIRIE | MN | 55344 |
| K141446 | NATUS MEDICAL INCORPORATED |
5900 FIRST AVENUE SOUTH | SEATTLE | WA | 98108 |
| K233649 | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) |
2568 Bristol Circle | Oakville | L6H 5S1 | |
| K013137 | NATUS MEDICAL, INC. |
1501 INDUSTRIAL RD. | SAN CARLOS | CA | 94070 |
| K030823 | NATUS MEDICAL, INC. |
1501 INDUSTRIAL RD. | SAN CARLOS | CA | 94070 |
| K073665 | NATUS MEDICAL, INC. |
1501 INDUSTRIAL RD. | SAN CARLOS | CA | 94070 |
| K211147 | Path Medical GmbH |
Landsberger Strasse 65 | Germering | 82110 | |
| K100661 | PATH MEDICAL GMBH |
4120 PICADILLY DRIVE | FORT COLLINS | CO | 80526 |
| K131141 | PATH MEDICAL GMBH |
LANDSBERGER STR 63 | GERMERING, BAVARIA | D-82110 | |
| K220139 | PATH MEDICAL GmbH |
Landsberger Strasse 65 | Germering | 82110 | |
| K111555 | R & D MEDICAL PRODUCTS, INC. |
20492 CRESCENT BAY DR. #106 | LAKE FOREST | CA | 92630 |
| K993177 | SLE LIMITED |
PO BOX 12038 | LA JOLLA | CA | 92037 |
| K011842 | SLE LIMITED |
PO BOX 12038 | LA JOLLA | CA | 92039-2038 |
| K012415 | SYNAPSYS, INC. |
150-10 132 AVE. | JAMAICA | NY | 11434 |
| K242954 | Vivosonic Inc |
222-5535 Eglinton Avenue West | Toronto | M9C 5K5 | |
| K043396 | VIVOSONIC, INC. |
56 ABERFOYLE CRESCENT | TORONTO, ON | M8X 2W4 | |
| K080060 | VIVOSONIC, INC. |
120-5525 EGLINTON AVENUE WEST | TORONTO, ON | M9C 5K5 |
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