K955800

Substantially Equivalent

SI2000 (SENSE-IT TRADEMARK) OR G2000; DISPOSABLE RESTING ELECTRODE

Applicant: Cmc Sense-It, Inc.
Product code: DRX
Advisory panel: Cardiovascular
Date received: 1995-12-22
Decision date: 1996-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hopkins, MN, US

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.