K001278 is an FDA 510(k) clearance for the SENSAIRE DIAGNOSTIC SPIROMETER. This device is classified as a Spirometer, Diagnostic (Class II - Special Controls, product code BZG).
Submitted by Qrs Diagnostic, LLC (Plymouth, US). The FDA issued a Cleared decision on November 29, 2000, 222 days after receiving the submission on April 21, 2000.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840.
| 510(k) Number | K001278 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 2000 |
| Decision Date | November 29, 2000 |
| Days to Decision | 222 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZG — Spirometer, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1840 |