OPHTHASONIC A/P III
FDA 510(k) clearance K903666 · decided 1990-11-19
Clearance details
- K-number
- K903666
- Device name
- OPHTHASONIC A/P III
- Applicant
- Teknar, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-08-14
- Decision date
- 1990-11-19
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- HPY
- Device class
- 1
- Regulation number
- 886.4250
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Fenton, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.