K923156 is an FDA 510(k) clearance for the TRACHEOSTOMY CARE TRAY. This device is classified as a Tube Tracheostomy And Tube Cuff (Class II - Special Controls, product code JOH).
Submitted by Orion Life Systems, Inc. (Wheeling, US). The FDA issued a Cleared decision on August 18, 1993, 415 days after receiving the submission on June 29, 1992.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5800.
| 510(k) Number | K923156 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | June 29, 1992 |
| Decision Date | August 18, 1993 |
| Days to Decision | 415 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | JOH — Tube Tracheostomy And Tube Cuff |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5800 |