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 |