Fiber Head Light FH-300
FDA 510(k) K951337 · Neitz Instruments Company, Ltd.
510(k) numberK951337
Submission
- Device name
- Fiber Head Light FH-300
- Applicant
- Neitz Instruments Company, Ltd.
Tokyo, JP - Received
- March 24, 1995
- Decision date
- June 8, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| K952289 | Welch Allyn Fiber Optic HeadligntHPQ · Traditional | Welch Allyn, Inc. | 07/14/1995SE |
| 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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| K951340 | Neitz Slit Lamp SL-H1HJO · Traditional | 04/10/1995SE |
| K951338 | Indirect Ophthalmoscope Video System IO0 a TVHLI · Traditional | 04/07/1995SE |
| K950797 | Halogen Ophthalmo-Otoscope Set BX a - 134HLJ · Traditional | 03/28/1995SE |
| K950795 | Streak Retinoscope Rx-RpHKM · Traditional | 03/28/1995SE |
| K950794 | Streak Retinoscope Rx-RcHKM · Traditional | 03/28/1995SE |
| K950793 | Spot Retinoscope RX-3SPHKM · Traditional | 03/28/1995SE |
| K950792 | Streak Retinoscope RX-3AHKM · Traditional | 03/28/1995SE |
Questions and answers
When was Fiber Head Light FH-300 cleared by the FDA?
Fiber Head Light FH-300 (K951337) received a 510(k) decision of Substantially Equivalent on June 8, 1995, 76 days after the submission was received.
What is the product code of K951337?
The FDA product code is HPQ – Headlamp, Operating, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4335.