K192966 is an FDA 510(k) clearance for the FlowMet. This device is classified as a Flowmeter, Blood, Cardiovascular (Class II - Special Controls, product code DPW).
Submitted by Laser Associated Sciences, Inc. (Irvine, US). The FDA issued a Cleared decision on January 10, 2020, 79 days after receiving the submission on October 23, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2100.
| 510(k) Number | K192966 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 2019 |
| Decision Date | January 10, 2020 |
| Days to Decision | 79 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPW - Flowmeter, Blood, Cardiovascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2100 |