510(k) K852638
K852638 is an FDA 510(k) premarket notification submitted by Zeiss Humphrey System for the device "HUMPHREY IMAGE ANALYZER MODEL 110". The FDA issued a decision of Substantially Equivalent on August 12, 1985. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Zeiss Humphrey System has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 1985
- Date Received
- June 20, 1985
- 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