PHYSIOGLOVE ES WITH ECG ANALYSIS— 510(k) K103791

Substantially Equivalent

Commwell , Ltd.

FDA 510(k) clearance K103791 for PHYSIOGLOVE ES WITH ECG ANALYSIS, Substantially Equivalent on 2011-10-21. Applicant: Commwell , Ltd..

Clearance details

Applicant: Commwell , Ltd.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2010-12-27
Decision date: 2011-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kfar Saba, IL

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.