AUDIOMETER CALIBRATOR MODEL RA 310
FDA 510(k) clearance K780474 · decided 1978-03-30
Clearance details
- K-number
- K780474
- Device name
- AUDIOMETER CALIBRATOR MODEL RA 310
- Applicant
- Tracor Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-03-24
- Decision date
- 1978-03-30
- Days to decision
- 6 days
- Clearance type
- Traditional
- Product code
- EWA
- Device class
- 1
- Regulation number
- 874.1080
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OTOVIEW ENDOSCOPY SYSTEM (K934432) | Smith & Nephew Richards, Inc. | 1994-04-25 |
Recalls involving this device
No recalls on record reference this clearance.