510(k) K822908
K822908 is an FDA 510(k) premarket notification submitted by Coherent Medical Division for the device "COHERENT FUNDUSL RETINAL CAMERA". The FDA issued a decision of Substantially Equivalent on January 5, 1983. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Coherent Medical Division has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 5, 1983
- Date Received
- September 30, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Ophthalmic, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1120
- Review Panel
- OP
- Submission Type