EMERGENCY TRACHEOSTOMY KIT
Device Facts
| Record ID | K823872 |
|---|---|
| Device Name | EMERGENCY TRACHEOSTOMY KIT |
| Applicant | Omnicon Medical Corp. |
| Product Code | EWC · Ear, Nose, Throat |
| Decision Date | Jan 21, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.1060 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An acoustic chamber for audiometric testing is a room that is intended for use in conducting diagnostic hearing evaluations and that eliminates sound reflections and provides isolation from outside sounds.