K082558 is an FDA 510(k) clearance for the COMFORTLITE NASAL MASK. This device is classified as a Ventilator, Non-continuous (respirator) (Class II - Special Controls, product code BZD).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on March 25, 2009, 202 days after receiving the submission on September 4, 2008.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K082558 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2008 |
| Decision Date | March 25, 2009 |
| Days to Decision | 202 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZD — Ventilator, Non-continuous (respirator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5905 |