K123176 is an FDA 510(k) clearance for the ISO-GARD CLEARAIR MASK. This device is classified as a Apparatus, Gas-scavenging (Class II - Special Controls, product code CBN).
Submitted by Teleflexmedical, Inc. (Research Triangle Park, US). The FDA issued a Cleared decision on February 14, 2013, 127 days after receiving the submission on October 10, 2012.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5430.
| 510(k) Number | K123176 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 2012 |
| Decision Date | February 14, 2013 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBN — Apparatus, Gas-scavenging |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5430 |