K190624 is an FDA 510(k) clearance for the EarlyVue VS30. This device is classified as a Alarm, Blood-pressure (Class II - Special Controls, product code DSJ).
Submitted by Philips Medizin Systeme Boeblingen GmbH (Boeblingen, DE). The FDA issued a Cleared decision on October 27, 2019, 230 days after receiving the submission on March 11, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1100.
| 510(k) Number | K190624 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 2019 |
| Decision Date | October 27, 2019 |
| Days to Decision | 230 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSJ — Alarm, Blood-pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1100 |