The following data is part of a premarket notification filed by Precision Acoustics Ind., Inc. with the FDA for Interacoustics Diagnostic Audiometer.
| Device ID | K942006 |
| 510k Number | K942006 |
| Device Name: | INTERACOUSTICS DIAGNOSTIC AUDIOMETER |
| Classification | Audiometer |
| Applicant | PRECISION ACOUSTICS IND., INC. 501 FIFTH AVE. New York, NY 10017 |
| Contact | Michael Davis |
| Correspondent | Michael Davis PRECISION ACOUSTICS IND., INC. 501 FIFTH AVE. New York, NY 10017 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-25 |
| Decision Date | 1994-06-20 |