K120639 is an FDA 510(k) clearance for the PERFORMAX PEDIATRIC SE TOTAL FACE MASK. This device is classified as a Ventilator, Continuous, Facility Use (Class II - Special Controls, product code CBK).
Submitted by Respironics, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on July 10, 2012, 130 days after receiving the submission on March 2, 2012.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K120639 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2012 |
| Decision Date | July 10, 2012 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBK — Ventilator, Continuous, Facility Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |