Head Mirrors W/Head Lamps & Head Bands
FDA 510(k) K822272 · Kelleher Corp.
510(k) numberK822272
Submission
- Device name
- Head Mirrors W/Head Lamps & Head Bands
- Applicant
- Kelleher Corp.
Mchenry, IL, US - Received
- July 29, 1982
- Decision date
- November 10, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Keeler Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K822618 | Emergency Tracheostomy Instrument SetLJW · Traditional | 01/28/1983SE |
| K822268 | Nagashima Ns-Iii ElectronystagmographGWN · Traditional | 01/28/1983SE |
| K823083 | Electrosurgical UnitGEI · Traditional | 12/07/1982SE |
| K823111 | Nystymograph AccessGNN · Traditional | 11/22/1982SE |
| K822252 | ENT Treatment UnitsETF · Traditional | 11/22/1982SE |
| K822017 | Tympanostomy Tubes & Various TypesETD · Traditional | 10/27/1982SE |
| K822257 | Various Types of Light Source HandlesEOQ · Traditional | 10/26/1982SE |
| K822259 | Laryngeal SpatulasEQH · Traditional | 10/22/1982SE |
| K822004 | Face ShieldsKNT · Traditional | 10/20/1982SE |
| K822185 | Laryngeal SyringeFMF · Traditional | 10/18/1982SE |
Questions and answers
When was Head Mirrors W/Head Lamps & Head Bands cleared by the FDA?
Head Mirrors W/Head Lamps & Head Bands (K822272) received a 510(k) decision of Substantially Equivalent on November 10, 1982, 104 days after the submission was received.
What is the product code of K822272?
The FDA product code is HPQ – Headlamp, Operating, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4335.