K951901 is an FDA 510(k) clearance for the MASTERSCREEN PFT BODY. This device is classified as a Plethysmograph, Volume (Class II - Special Controls, product code JEH).
Submitted by Erich Jaeger GmbH & Co. KG (Hoechberg, DE). The FDA issued a Cleared decision on July 31, 1995, 98 days after receiving the submission on April 24, 1995.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1760.
| 510(k) Number | K951901 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 1995 |
| Decision Date | July 31, 1995 |
| Days to Decision | 98 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 |