VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor bag of 20, VitalPatch 7D Biosensor bag of 20— 510(k) K192757

Substantially Equivalent

Vitalconnect, Inc.

FDA 510(k) clearance K192757 for VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor bag of 20, VitalPatch 7D Biosensor bag of 20, Substantially Equivalent on 2020-02-06. Applicant: Vitalconnect, Inc..

Clearance details

Applicant: Vitalconnect, Inc.
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 2019-09-30
Decision date: 2020-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, 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.