COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR— 510(k) K970769

Substantially Equivalent

Aristo Medical

FDA 510(k) clearance K970769 for COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR, Substantially Equivalent on 1997-08-28. Applicant: Aristo Medical.

Clearance details

Applicant: Aristo Medical
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 1997-03-03
Decision date: 1997-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

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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.