ETV, ELECTRONIC VISION AID
FDA 510(k) clearance K884540 · decided 1989-01-19
Clearance details
- K-number
- K884540
- Device name
- ETV, ELECTRONIC VISION AID
- Applicant
- Sevrain-Tech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-10-28
- Decision date
- 1989-01-19
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- HPE
- Device class
- 1
- Regulation number
- 886.5915
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Madison, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.