K942395 is an FDA 510(k) clearance for the ENDOTRACHEAL TUBE HOLDER. This device is classified as a Device, Fixation, Tracheal Tube (Class I - General Controls, product code CBH).
Submitted by S.T.I. Medical Products Corp. (Newport Beach, US). The FDA issued a Cleared decision on June 30, 1994, 42 days after receiving the submission on May 19, 1994.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5770.
| 510(k) Number | K942395 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 1994 |
| Decision Date | June 30, 1994 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CBH — Device, Fixation, Tracheal Tube |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5770 |