K132729 is an FDA 510(k) clearance for the ISO-GARD MASK. This device is classified as a Apparatus, Gas-scavenging (Class II - Special Controls, product code CBN).
Submitted by Teleflexmedical, Inc. (Durham, US). The FDA issued a Cleared decision on January 9, 2014, 128 days after receiving the submission on September 3, 2013.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5430.
| 510(k) Number | K132729 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2013 |
| Decision Date | January 09, 2014 |
| Days to Decision | 128 days |
| Submission Type | Special |
| 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 |