K080510 is an FDA 510(k) clearance for the VIP PULMONARY FUNCTION SYSTEM. This device is classified as a Calculator, Predicted Values, Pulmonary Function (Class II - Special Controls, product code BTY).
Submitted by Viasys Healthcare GmbH (Hoechberg, DE). The FDA issued a Cleared decision on August 20, 2008, 177 days after receiving the submission on February 25, 2008.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K080510 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 2008 |
| Decision Date | August 20, 2008 |
| Days to Decision | 177 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BTY — Calculator, Predicted Values, Pulmonary Function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1890 |