K053466 is an FDA 510(k) clearance for the HSINER RESUSCITATOR. This device is classified as a Ventilator, Emergency, Manual (resuscitator) (Class II - Special Controls, product code BTM).
Submitted by Hsiner Co., Ltd. (Temecula, US). The FDA issued a Cleared decision on March 22, 2006, 99 days after receiving the submission on December 13, 2005.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5915.
| 510(k) Number | K053466 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2005 |
| Decision Date | March 22, 2006 |
| Days to Decision | 99 days |
| Submission Type | Abbreviated |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTM — Ventilator, Emergency, Manual (resuscitator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5915 |