The following data is part of a premarket notification filed by Tracor Instruments, Inc. with the FDA for Audiometer Calibrator Model Ra 310.
| Device ID | K780474 |
| 510k Number | K780474 |
| Device Name: | AUDIOMETER CALIBRATOR MODEL RA 310 |
| Classification | Set, Audiometer Calibration |
| Applicant | TRACOR INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EWA |
| CFR Regulation Number | 874.1080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-24 |
| Decision Date | 1978-03-30 |