K041781 is an FDA 510(k) clearance for the VENTILAIR II MEDICAL AIR COMPRESSOR. This device is classified as a Compressor, Air, Portable (Class II - Special Controls, product code BTI).
Submitted by Hamilton Medical AG (Reno, US). The FDA issued a Cleared decision on March 14, 2005, 256 days after receiving the submission on July 1, 2004.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.6250.
| 510(k) Number | K041781 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2004 |
| Decision Date | March 14, 2005 |
| Days to Decision | 256 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTI — Compressor, Air, Portable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.6250 |