K954140 is an FDA 510(k) clearance for the MASTERSCREEN IOS. This device is classified as a Spirometer, Diagnostic (Class II - Special Controls, product code BZG).
Submitted by Erich Jaeger GmbH & Co. KG (Wurzburg D-97008, DE). The FDA issued a Cleared decision on December 14, 1995, 104 days after receiving the submission on September 1, 1995.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840.
| 510(k) Number | K954140 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 1995 |
| Decision Date | December 14, 1995 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BZG — Spirometer, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1840 |