K936108 is an FDA 510(k) clearance for the MASTERSCREEN BODY. This device is classified as a Plethysmograph, Volume (Class II - Special Controls, product code JEH).
Submitted by Erich Jaeger GmbH & Co. KG (Wuerzburg, Germany, DE). The FDA issued a Cleared decision on February 3, 1995, 403 days after receiving the submission on December 27, 1993.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1760.
| 510(k) Number | K936108 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 1993 |
| Decision Date | February 03, 1995 |
| Days to Decision | 403 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 |