K231313 is an FDA 510(k) clearance for the Therapy Mask 3100 NC/SP. 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 July 28, 2023, 84 days after receiving the submission on May 5, 2023.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K231313 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 2023 |
| Decision Date | July 28, 2023 |
| Days to Decision | 84 days |
| Submission Type | Special |
| 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 |