Vitls Platform— 510(k) K191620

Substantially Equivalent

Vitls, Inc.

FDA 510(k) clearance K191620 for Vitls Platform, Substantially Equivalent on 2020-06-01. Applicant: Vitls, Inc..

Clearance details

Applicant: Vitls, Inc.
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 2019-06-18
Decision date: 2020-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.