The following data is part of a premarket notification filed by Omnicon Medical Corp. with the FDA for Emergency Tracheostomy Kit.
| Device ID | K823872 |
| 510k Number | K823872 |
| Device Name: | EMERGENCY TRACHEOSTOMY KIT |
| Classification | Chamber, Acoustic (for Audiometric Testing) |
| Applicant | OMNICON MEDICAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EWC |
| CFR Regulation Number | 874.1060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-27 |
| Decision Date | 1983-01-21 |