K822794 is an FDA 510(k) clearance for the RESPIRONICS ENDO TUBE CONTROL SYS. This device is classified as a Device, Fixation, Tracheal Tube (Class I - General Controls, product code CBH).
Submitted by Respironics, Inc. (Monroeville, US). The FDA issued a Cleared decision on October 22, 1982, 36 days after receiving the submission on September 16, 1982.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5770.
| 510(k) Number | K822794 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 1982 |
| Decision Date | October 22, 1982 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CBH — Device, Fixation, Tracheal Tube |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5770 |