K071753 is an FDA 510(k) clearance for the MASTERSCREEN PNEUMO & MASTERSCOPE. This device is classified as a Calculator, Predicted Values, Pulmonary Function (Class II - Special Controls, product code BTY).
Submitted by Viasys Healthcare GmbH (Yorba Linda, US). The FDA issued a Cleared decision on August 14, 2007, 47 days after receiving the submission on June 28, 2007.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K071753 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2007 |
| Decision Date | August 14, 2007 |
| Days to Decision | 47 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTY — Calculator, Predicted Values, Pulmonary Function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1890 |