K023796 is an FDA 510(k) clearance for the MS PAED-BABY BODY. This device is classified as a Plethysmograph, Pressure (Class II - Special Controls, product code CCM).
Submitted by Erich Jaeger GmbH (Yorba Linda, US). The FDA issued a Cleared decision on March 3, 2003, 110 days after receiving the submission on November 13, 2002.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1750.
| 510(k) Number | K023796 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2002 |
| Decision Date | March 03, 2003 |
| Days to Decision | 110 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CCM — Plethysmograph, Pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1750 |