K200550 is an FDA 510(k) clearance for the Vitalograph Model 2120 In2itive eDiary. 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 July 27, 2020, 146 days after receiving the submission on March 3, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840.
| 510(k) Number | K200550 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2020 |
| Decision Date | July 27, 2020 |
| 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 |