K192146 is an FDA 510(k) clearance for the V-DENUPET. This device is classified as a Microtools, Assisted Reproduction (pipettes) (Class II - Special Controls, product code MQH).
Submitted by Vitromed GmbH (Jena, DE). The FDA issued a Cleared decision on January 28, 2020, 173 days after receiving the submission on August 8, 2019.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6130.
| 510(k) Number | K192146 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 2019 |
| Decision Date | January 28, 2020 |
| Days to Decision | 173 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQH - Microtools, Assisted Reproduction (pipettes) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6130 |