K013306 is an FDA 510(k) clearance for the MINIME NASAL MASK, MODEL P/N 50220. This device is classified as a Ventilator, Non-continuous (respirator) (Class II - Special Controls, product code BZD).
Submitted by Sleepnet Corporation (Manchester, US). The FDA issued a Cleared decision on November 2, 2001, 29 days after receiving the submission on October 4, 2001.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K013306 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 2001 |
| Decision Date | November 02, 2001 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BZD — Ventilator, Non-continuous (respirator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5905 |