The following data is part of a premarket notification filed by Micro Audiometrics Corp. with the FDA for Earscan 3.
| Device ID | K982878 |
| 510k Number | K982878 |
| Device Name: | EARSCAN 3 |
| Classification | Audiometer |
| Applicant | MICRO AUDIOMETRICS CORP. 2200 SO.RIDGEWOOD AVE. South Daytona, FL 32119 -3018 |
| Contact | Jason R Keller |
| Correspondent | Jason R Keller MICRO AUDIOMETRICS CORP. 2200 SO.RIDGEWOOD AVE. South Daytona, FL 32119 -3018 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-14 |
| Decision Date | 1998-11-03 |
| Summary: | summary |