K221030 is an FDA 510(k) clearance for the Model 9100 PFT/DICO. This device is classified as a Calculator, Predicted Values, Pulmonary Function (Class II - Special Controls, product code BTY).
Submitted by Vitalograph (Ireland) , Ltd. (Ennis Co Clare, IE). The FDA issued a Cleared decision on July 15, 2022, 99 days after receiving the submission on April 7, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K221030 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 2022 |
| Decision Date | July 15, 2022 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTY - Calculator, Predicted Values, Pulmonary Function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1890 |