Head Mirror with Headband
FDA 510(k) K822191 · Kelleher Corp.
510(k) numberK822191
Submission
- Device name
- Head Mirror with Headband
- Applicant
- Kelleher Corp.
Mchenry, IL, US - Received
- July 23, 1982
- Decision date
- August 20, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KAI – Mirror, Ent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code KAI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K833601 | Antrum & Attic MirrorKAI · Traditional | Microtek Medical, Inc. | 01/03/1984SE |
| K823915 | Mirror TipKAI · Traditional | Treace Medical, Inc. | 01/21/1983SE |
| K822374 | Buckingham Attic & Antrum MirrorKAI · Traditional | Treace Medical, Inc. | 09/09/1982SE |
| K822261 | Laryngeal MirrorsKAI · Traditional | Kelleher Corp. | 08/30/1982SE |
| K820354 | Atmos Mirror WarmerKAI · Traditional | Jedmed Instrument Co. | 03/01/1982SE |
| K781750 | Mirror WarmerKAI · Traditional | Arleton Technical Products, Inc. | 01/17/1979SE |
| K770054 | Mirror, Naso-PharynxKAI · Traditional | Welch Allyn, Inc. | 01/18/1977SE |
| K770053 | Mirror, LaryngealKAI · Traditional | Welch Allyn, Inc. | 01/18/1977SE |
More from Welch Allyn, 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 |
| K822272 | Head Mirrors W/Head Lamps & Head BandsHPQ · Traditional | 11/10/1982SE |
| 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 |
Questions and answers
When was Head Mirror with Headband cleared by the FDA?
Head Mirror with Headband (K822191) received a 510(k) decision of Substantially Equivalent on August 20, 1982, 28 days after the submission was received.
What is the product code of K822191?
The FDA product code is KAI – Mirror, Ent, a Class I (low risk) device regulated under 21 CFR 874.4420.