K022636 is an FDA 510(k) clearance for the BODY BOX 5500. This device is classified as a Plethysmograph, Volume (Class II - Special Controls, product code JEH).
Submitted by Morgan Scientific, Inc. (Haverhill, US). The FDA issued a Cleared decision on January 13, 2003, 158 days after receiving the submission on August 8, 2002.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1760.
| 510(k) Number | K022636 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 2002 |
| Decision Date | January 13, 2003 |
| Days to Decision | 158 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 |