K200567 is an FDA 510(k) clearance for the ASI Plethysmogrpah Analyzer. This device is classified as a Plethysmograph, Photoelectric, Pneumatic Or Hydraulic (Class II - Special Controls, product code JOM).
Submitted by Arterial Stiffness, Inc. (Saint Paul, US). The FDA issued a Cleared decision on February 26, 2021, 359 days after receiving the submission on March 4, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2780.
| 510(k) Number | K200567 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2020 |
| Decision Date | February 26, 2021 |
| Days to Decision | 359 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | JOM - Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2780 |