WELCH ALLYN FIBER OPTIC HEADLIGNT
FDA 510(k) clearance K952289 · decided 1995-07-14
Clearance details
- K-number
- K952289
- Device name
- WELCH ALLYN FIBER OPTIC HEADLIGNT
- Applicant
- Welch Allyn, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-05-16
- Decision date
- 1995-07-14
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- HPQ
- Device class
- 2
- Regulation number
- 886.4335
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Skaneateles Falls, NY, 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 |
|---|---|---|
| FIBER HEAD LIGHT FH-300 (K951337) | Neitz Instruments Company, Ltd. | 1995-06-08 |
| KEELER FIBEROPTIC HEADLAMP (K861747) | Keeler Instruments, Inc. | 1986-08-21 |
| KEELER DUAL LIGHTSOURCE (K861746) | Keeler Instruments, Inc. | 1986-08-21 |
| HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS (K822272) | Kelleher Corp. | 1982-11-10 |
Recalls involving this device
No recalls on record reference this clearance.