K042595 is an FDA 510(k) clearance for the SPIRO'AIR. This device is classified as a Spirometer, Diagnostic (Class II - Special Controls, product code BZG).
Submitted by Morgan Scientific, Inc. (Haverhill, US). The FDA issued a Cleared decision on May 4, 2005, 223 days after receiving the submission on September 23, 2004.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840.
| 510(k) Number | K042595 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2004 |
| Decision Date | May 04, 2005 |
| Days to Decision | 223 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 |