The following data is part of a premarket notification filed by Micro Audiometrics Corp. with the FDA for Earscan.
Device ID | K812529 |
510k Number | K812529 |
Device Name: | EARSCAN |
Classification | Audiometer |
Applicant | MICRO AUDIOMETRICS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | EWO |
CFR Regulation Number | 874.1050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-09-02 |
Decision Date | 1981-10-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() EARSCAN 77146002 3311607 Live/Registered |
MICRO AUDIOMETRICS CORP. 2007-04-02 |
![]() EARSCAN 74532979 1950230 Dead/Cancelled |
Micro Audiometrics Corp. 1994-06-03 |
![]() EARSCAN 74373468 not registered Dead/Abandoned |
Lowell Shoe, Inc. 1993-03-30 |