510(k) K891610
K891610 is an FDA 510(k) premarket notification submitted by Keeler Instruments, Inc. for the device "HENSON CFA 3000 CENTRAL VISUAL FIELD SCREENER". The FDA issued a decision of Substantially Equivalent on June 5, 1989. The device falls under product code HOD (Clamp, Eyelid, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Keeler Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 5, 1989
- Date Received
- March 20, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Eyelid, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.4350
- Review Panel
- OP
- Submission Type