K081823 is an FDA 510(k) clearance for the MASTERSCREEN PAED - BABY BODY. This device is classified as a Plethysmograph, Pressure (Class II - Special Controls, product code CCM).
Submitted by Viasys Healthcare GmbH (Hoechberg, DE). The FDA issued a Cleared decision on May 18, 2009, 325 days after receiving the submission on June 27, 2008.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1750.
| 510(k) Number | K081823 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2008 |
| Decision Date | May 18, 2009 |
| Days to Decision | 325 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CCM — Plethysmograph, Pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1750 |