The following data is part of a premarket notification filed by Micro Audiometrics Corp. with the FDA for Biometer Audiometer.
| Device ID | K883505 |
| 510k Number | K883505 |
| Device Name: | BIOMETER AUDIOMETER |
| Classification | Audiometer |
| Applicant | MICRO AUDIOMETRICS CORP. 3749-B S. NOVA RD. Port Orange, FL 32129 -4233 |
| Contact | Kathleen A Keller |
| Correspondent | Kathleen A Keller MICRO AUDIOMETRICS CORP. 3749-B S. NOVA RD. Port Orange, FL 32129 -4233 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-17 |
| Decision Date | 1989-08-21 |