K112783 is an FDA 510(k) clearance for the MANUJET III. This device is classified as a Ventilator, Emergency, Powered (resuscitator) (Class II - Special Controls, product code BTL).
Submitted by VBM Medizintechnik GmbH (Baden-Wurttemberg, DE). The FDA issued a Cleared decision on December 22, 2011, 87 days after receiving the submission on September 26, 2011.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5925.
| 510(k) Number | K112783 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2011 |
| Decision Date | December 22, 2011 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BTL - Ventilator, Emergency, Powered (resuscitator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5925 |