K021200 is an FDA 510(k) clearance for the COMPAS. 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 October 18, 2002, 185 days after receiving the submission on April 16, 2002.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840.
| 510(k) Number | K021200 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2002 |
| Decision Date | October 18, 2002 |
| Days to Decision | 185 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 |