The following data is part of a premarket notification filed by Fischer-zoth Audiologic Systems, Inc. with the FDA for Echo-screen T, Ta, Td, Tda, Tc.
| Device ID | K013977 |
| 510k Number | K013977 |
| Device Name: | ECHO-SCREEN T, TA, TD, TDA, TC |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | FISCHER-ZOTH AUDIOLOGIC SYSTEMS, INC. 1257 WEST MARGARET VIEW CIRCLE Riverton, UT 84065 |
| Contact | Michael Soerensen |
| Correspondent | Michael Soerensen FISCHER-ZOTH AUDIOLOGIC SYSTEMS, INC. 1257 WEST MARGARET VIEW CIRCLE Riverton, UT 84065 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-03 |
| Decision Date | 2002-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830054430 | K013977 | 000 |
| 00382830044486 | K013977 | 000 |
| 00382830051231 | K013977 | 000 |
| 00382830054164 | K013977 | 000 |
| 00382830054171 | K013977 | 000 |
| 00382830054188 | K013977 | 000 |
| 00382830054201 | K013977 | 000 |
| 00382830054249 | K013977 | 000 |
| 00382830054256 | K013977 | 000 |
| 00382830054263 | K013977 | 000 |
| 00382830054270 | K013977 | 000 |
| 00382830054331 | K013977 | 000 |
| 00382830054348 | K013977 | 000 |
| 00382830054355 | K013977 | 000 |
| 00382830054362 | K013977 | 000 |
| 00382830054379 | K013977 | 000 |
| 00382830054386 | K013977 | 000 |
| 00382830054393 | K013977 | 000 |
| 00382830044479 | K013977 | 000 |