ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)— 510(k) K120253

Substantially Equivalent

Elcam Medical Acal

FDA 510(k) clearance K120253 for ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS), Substantially Equivalent on 2012-07-16. Applicant: Elcam Medical Acal.

Clearance details

Applicant: Elcam Medical Acal
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 2012-01-27
Decision date: 2012-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mp. Merom Hagalil, IL

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.