K212938 is an FDA 510(k) clearance for the Vitalograph Model 6000 Alpha. This device is classified as a Spirometer, Diagnostic (Class II - Special Controls, product code BZG).
Submitted by Vitalograph (Ireland) , Ltd. (Ennis Co Clare, IE). The FDA issued a Cleared decision on January 26, 2022, 133 days after receiving the submission on September 15, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840.
| 510(k) Number | K212938 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2021 |
| Decision Date | January 26, 2022 |
| Days to Decision | 133 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 |