The following data is part of a premarket notification filed by Micro Audiometrics Corp. with the FDA for Biolink Audiometer Software Accessory.
| Device ID | K904270 |
| 510k Number | K904270 |
| Device Name: | BIOLINK AUDIOMETER SOFTWARE ACCESSORY |
| Classification | Audiometer |
| Applicant | MICRO AUDIOMETRICS CORP. 2200 SO. RIDGEWOOD AVENUE, US#1 South Daytona, FL 32119 |
| Contact | Aaron Margosis |
| Correspondent | Aaron Margosis MICRO AUDIOMETRICS CORP. 2200 SO. RIDGEWOOD AVENUE, US#1 South Daytona, FL 32119 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-18 |
| Decision Date | 1990-10-09 |