The following data is part of a premarket notification filed by Idem (int'l Dist. Of Electronics For Medicine) with the FDA for Interacoustics Model Az26 Clinical Impedance Audiometer.
| Device ID | K990652 |
| 510k Number | K990652 |
| Device Name: | INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER |
| Classification | Tester, Auditory Impedance |
| Applicant | IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) 4814 EAST SECOND ST. Benicia, CA 94510 |
| Contact | Donna Ward |
| Correspondent | Donna Ward IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) 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 | 1999-03-01 |
| Decision Date | 1999-05-17 |
| Summary: | summary |