K093174 is an FDA 510(k) clearance for the SPIROPALM. This device is classified as a Spirometer, Diagnostic (Class II - Special Controls, product code BZG).
Submitted by Cosmed Srl (West Caldwell, US). The FDA issued a Cleared decision on February 26, 2010, 141 days after receiving the submission on October 8, 2009.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840.
| 510(k) Number | K093174 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 08, 2009 |
| Decision Date | February 26, 2010 |
| Days to Decision | 141 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 |