The following data is part of a premarket notification filed by International Distributors Of Electronics For Medi with the FDA for Interacoustics At235 Impedance Audiometer.
| Device ID | K994254 |
| 510k Number | K994254 |
| Device Name: | INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER |
| Classification | Tester, Auditory Impedance |
| Applicant | INTERNATIONAL DISTRIBUTORS OF ELECTRONICS FOR MEDI 4814 EAST SECOND ST. Benicia, CA 94510 |
| Contact | Donna Ward |
| Correspondent | Donna Ward INTERNATIONAL DISTRIBUTORS OF ELECTRONICS FOR MEDI 4814 EAST SECOND ST. Benicia, CA 94510 |
| Product Code | ETY |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-17 |
| Decision Date | 2000-03-14 |
| Summary: | summary |