The following data is part of a premarket notification filed by Tracor Instruments Austin, Inc. with the FDA for Tracor Ra500 Audiometer.
Device ID | K891373 |
510k Number | K891373 |
Device Name: | TRACOR RA500 AUDIOMETER |
Classification | Audiometer |
Applicant | TRACOR INSTRUMENTS AUSTIN, INC. 6500 TRACOR LN. Austin, TX 78725 |
Contact | Jack C Foreman |
Correspondent | Jack C Foreman TRACOR INSTRUMENTS AUSTIN, INC. 6500 TRACOR LN. Austin, TX 78725 |
Product Code | EWO |
CFR Regulation Number | 874.1050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-09 |
Decision Date | 1989-07-14 |