K191013 is an FDA 510(k) clearance for the Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option. This device is classified as a Spirometer, Diagnostic (Class II - Special Controls, product code BZG).
Submitted by Welch Allyn, Inc. (Milwaukee, US). The FDA issued a Cleared decision on September 10, 2019, 146 days after receiving the submission on April 17, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840.
| 510(k) Number | K191013 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2019 |
| Decision Date | September 10, 2019 |
| Days to Decision | 146 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 |