The following data is part of a premarket notification filed by Micro Audiometrics Corp. with the FDA for Dsp Screening Audiometer.
Device ID | K924543 |
510k Number | K924543 |
Device Name: | DSP SCREENING AUDIOMETER |
Classification | Audiometer |
Applicant | MICRO AUDIOMETRICS CORP. 2200 SO. RIDGEWOOD AVENUE, US#1 South Daytona, FL 32119 |
Contact | Larry Debernardo |
Correspondent | Larry Debernardo 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 | 1992-09-08 |
Decision Date | 1993-02-26 |