Atmos Mirror Warmer
FDA 510(k) K820354 · Jedmed Instrument Co.
510(k) numberK820354
Submission
- Device name
- Atmos Mirror Warmer
- Applicant
- Jedmed Instrument Co.
Walker, MI, US - Received
- February 8, 1982
- Decision date
- March 1, 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 |
| K822191 | Head Mirror with HeadbandKAI · Traditional | Kelleher Corp. | 08/20/1982SE |
| 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 |
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| K021750 | Lid Chain Eyelid WeightsMML · Traditional | 01/27/2003SE |
| K954184 | Jed-Light Fiberoptic Light SourceEQH · Traditional | 11/13/1995SE |
| K944032 | Video Scope System (Laryngoscope)ENZ · Traditional | 09/15/1995SE |
| K953457 | Jedmed Spectrum ENT CabinetETF · Traditional | 08/11/1995SE |
| K950925 | Jedmed Laryngeal ScopeEOQ · Traditional | 08/11/1995SE |
| K950785 | Hortmann Airmatic Air Caloric StimulatorKHH · Traditional | 06/28/1995SE |
| K950078 | Microflow Irrigation SystemKMA · Traditional | 06/21/1995SE |
| K944671 | Video Scope System (Nasopharyngoscope {Flexible or Rigid})EOB · Traditional | 02/07/1995SE |
Questions and answers
When was Atmos Mirror Warmer cleared by the FDA?
Atmos Mirror Warmer (K820354) received a 510(k) decision of Substantially Equivalent on March 1, 1982, 21 days after the submission was received.
What is the product code of K820354?
The FDA product code is KAI – Mirror, Ent, a Class I (low risk) device regulated under 21 CFR 874.4420.