HENSON CFA 3000 CENTRAL VISUAL FIELD SCREENER
FDA 510(k) clearance K891610 · decided 1989-06-05
Clearance details
- K-number
- K891610
- Device name
- HENSON CFA 3000 CENTRAL VISUAL FIELD SCREENER
- Applicant
- Keeler Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-03-20
- Decision date
- 1989-06-05
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- HOD
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Broomall, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BURTON AUTOMATIC PROJECTOR - MODEL CP-40 (K924774) | R.H. Burton Co. | 1993-04-14 |
| SURGICAL/LID MARGIN COVER & EYELASH- (K831285) | Richard R. Anthony, M.D. | 1983-06-03 |
Recalls involving this device
No recalls on record reference this clearance.