ENT Treatment Units
FDA 510(k) K822252 · Kelleher Corp.
510(k) numberK822252
Submission
- Device name
- ENT Treatment Units
- Applicant
- Kelleher Corp.
Walker, MI, US - Received
- July 29, 1982
- Decision date
- November 22, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ETF – Unit, Examining/Treatment, Ent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.5300
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code ETF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K953457 | Jedmed Spectrum ENT CabinetETF · Traditional | Jedmed Instrument Co. | 08/11/1995SE |
| K945395 | Premier Mirror WarmerETF · Traditional | Premier Dental Products Co. | 01/18/1995SE |
| K932470 | Langgasse 90ETF · Traditional | Happersberger Otopront GmbH | 08/25/1993SE |
| K911901 | Maxi Cabinet Optional Built in S6000 Light SourceETF · Traditional | Stortz | 07/26/1991SE |
| K910781 | #491 Power Otolaryngoly CH/#498 Proced CTR & AccesETF · Traditional | Midmark Corp. | 05/15/1991SE |
| K910243 | Mobile Treatment CartETF · Traditional | Jedmed Instrument Co. | 04/17/1991SE |
| K896298 | Jedmed S ChairETF · Traditional | Jedmed Instrument Co. | 01/26/1990SE |
| K896273 | Systema ENT CabinetETF · Traditional | Jedmed Instrument Co. | 01/26/1990SE |
| K881958 | Jedmed Maxim ENT CabinetETF · Traditional | Jedmed Instrument Co. | 07/15/1988SE |
| K860940 | Micromedics Sterile, Disposable ENT Exam KitETF · Traditional | Micromedics, Inc. | 05/02/1986SE |
More from Micromedics, 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 |
| 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 |
| K822185 | Laryngeal SyringeFMF · Traditional | 10/18/1982SE |
Questions and answers
When was ENT Treatment Units cleared by the FDA?
ENT Treatment Units (K822252) received a 510(k) decision of Substantially Equivalent on November 22, 1982, 116 days after the submission was received.
What is the product code of K822252?
The FDA product code is ETF – Unit, Examining/Treatment, Ent, a Class I (low risk) device regulated under 21 CFR 874.5300.