SENTEC DIGITAL MONITORING SYSTEM— 510(k) K071672

Substantially Equivalent

Sentec AG

FDA 510(k) clearance K071672 for SENTEC DIGITAL MONITORING SYSTEM, Substantially Equivalent on 2007-09-12. Applicant: Sentec AG.

Clearance details

Applicant: Sentec AG
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2007-06-19
Decision date: 2007-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Egale, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.