Emergency Tracheostomy Kit
FDA 510(k) K823872 · Omnicon Medical Corp.
510(k) numberK823872
Submission
- Device name
- Emergency Tracheostomy Kit
- Applicant
- Omnicon Medical Corp.
Walker, MI, US - Received
- December 27, 1982
- Decision date
- January 21, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EWC – Chamber, Acoustic (For Audiometric Testing)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.1060
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code EWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K822269 | Nagashima SN Sound-Proof Chamber-HearingEWC · Traditional | Kelleher Corp. | 09/09/1982SE |
More from Kelleher Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K820577 | Anesthesia Bacteria FilterCAH · Traditional | 03/18/1982SE |
| K820576 | Mainflow Bacteria FilterCAH · Traditional | 03/18/1982SE |
| K801804 | Anesthesia Bacteria FilterCAH · Traditional | 08/13/1980SE |
| K801803 | Mainflow Bacteria FilterCAH · Traditional | 08/13/1980SE |
| K772060 | Protect IV GardFMP · Traditional | 12/20/1977SE |
| K770136 | Disposable Bacteria FilterCAH · Traditional | 02/14/1977SE |
| K770001 | Airway, Berman 40, 60, 80, 90, L00MM'SCAE · Traditional | 01/12/1977SE |
| K760819 | Conductive Anesthesia Breathing CircuitCAI · Traditional | 10/27/1976SE |
| K760149 | Conductive Anesthsia Breath. CircuitCAI · Traditional | 07/19/1976SE |
Questions and answers
When was Emergency Tracheostomy Kit cleared by the FDA?
Emergency Tracheostomy Kit (K823872) received a 510(k) decision of Substantially Equivalent on January 21, 1983, 25 days after the submission was received.
What is the product code of K823872?
The FDA product code is EWC – Chamber, Acoustic (For Audiometric Testing), a Class I (low risk) device regulated under 21 CFR 874.1060.