K211068 is an FDA 510(k) clearance for the PrevisEA Device. This device is classified as a Stethoscope, Electronic (Class II - Special Controls, product code DQD).
Submitted by Entac Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on August 4, 2021, 114 days after receiving the submission on April 12, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 870.1875.
| 510(k) Number | K211068 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 2021 |
| Decision Date | August 04, 2021 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | DQD - Stethoscope, Electronic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1875 |