K072061 is an FDA 510(k) clearance for the MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY. This device is classified as a Plethysmograph, Volume (Class II - Special Controls, product code JEH).
Submitted by Viasys Healthcare GmbH (Yorba Linda, US). The FDA issued a Cleared decision on April 22, 2008, 270 days after receiving the submission on July 27, 2007.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1760.
| 510(k) Number | K072061 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 2007 |
| Decision Date | April 22, 2008 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | JEH — Plethysmograph, Volume |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1760 |