K063268 is an FDA 510(k) clearance for the CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235. This device is classified as a Ventilator, Non-continuous (respirator) (Class II - Special Controls, product code BZD).
Submitted by Hsiner Co., Ltd. (Temecula, US). The FDA issued a Cleared decision on February 23, 2007, 116 days after receiving the submission on October 30, 2006.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K063268 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2006 |
| Decision Date | February 23, 2007 |
| Days to Decision | 116 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 |