510(k) K934432
- Device
- OTOVIEW ENDOSCOPY SYSTEM
- Applicant
- SMITH & NEPHEW RICHARDS, INC.
- 510(k) number
- K934432
- Product code
- EWA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-04-25
- Date received
- 1993-09-13
- Regulation
- 874.1080
- Classification name
- Set, Audiometer Calibration
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RONALD K SMITH
- Address
- 2929 Appling Rd. Bartlett TN US 38133 38133
FDA Registration Numbers#
- 1037007
- 1928237
- 3011310592
- 3011050570
- 9710051
- 3003790304
Source Documents#
Other 510(k) Records For Product Code EWA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K780474 | AUDIOMETER CALIBRATOR MODEL RA 310 | Tracor Instruments, Inc. | 1978-03-30 |
Legacy Summary#
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FDA Review#
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