Welch Allyn Fiber Optic Headlignt
FDA 510(k) K952289 · Welch Allyn, Inc.
510(k) numberK952289
Submission
- Device name
- Welch Allyn Fiber Optic Headlignt
- Applicant
- Welch Allyn, Inc.
Skaneateles Falls, NY, US - Received
- May 16, 1995
- Decision date
- July 14, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HPQ – Headlamp, Operating, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4335
- Specialty
- Ophthalmic
Other 510(k)s with product code HPQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K951337 | Fiber Head Light FH-300HPQ · Traditional | Neitz Instruments Company, Ltd. | 06/08/1995SE |
| K861747 | Keeler Fiberoptic HeadlampHPQ · Traditional | Keeler Instruments, Inc. | 08/21/1986SE |
| K861746 | Keeler Dual LightsourceHPQ · Traditional | Keeler Instruments, Inc. | 08/21/1986SE |
| K822272 | Head Mirrors W/Head Lamps & Head BandsHPQ · Traditional | Kelleher Corp. | 11/10/1982SE |
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Questions and answers
When was Welch Allyn Fiber Optic Headlignt cleared by the FDA?
Welch Allyn Fiber Optic Headlignt (K952289) received a 510(k) decision of Substantially Equivalent on July 14, 1995, 59 days after the submission was received.
What is the product code of K952289?
The FDA product code is HPQ – Headlamp, Operating, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4335.