G3000 OR AG2000; DISPOSABLE RESTING ELECTRODE— 510(k) K955815

Substantially Equivalent

Cmc Sense-It, Inc.

FDA 510(k) clearance K955815 for G3000 OR AG2000; DISPOSABLE RESTING ELECTRODE, Substantially Equivalent on 1996-07-23. Applicant: Cmc Sense-It, Inc..

Clearance details

Applicant: Cmc Sense-It, Inc.
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1995-12-26
Decision date: 1996-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hopkins, MN, US

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Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.