K912197 is an FDA 510(k) clearance for the SKIN SAVER(TM) TUBING HOLDER, MODEL 467. This device is classified as a Cannula, Nasal, Oxygen (Class I - General Controls, product code CAT).
Submitted by Alpine Specialties, Inc. (Loveland, US). The FDA issued a Cleared decision on August 20, 1991, 95 days after receiving the submission on May 17, 1991.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5340.
| 510(k) Number | K912197 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 1991 |
| Decision Date | August 20, 1991 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CAT — Cannula, Nasal, Oxygen |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5340 |