K843846 is an FDA 510(k) clearance for the UNIVERSAL-BODYTEST. This device is classified as a Plethysmograph, Pressure (Class II - Special Controls, product code CCM).
Submitted by Erich Jaeger, Inc. (Walker, US). The FDA issued a Cleared decision on February 14, 1985, 136 days after receiving the submission on October 1, 1984.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1750.
| 510(k) Number | K843846 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 1984 |
| Decision Date | February 14, 1985 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CCM — Plethysmograph, Pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1750 |