COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR— 510(k) K960251

Substantially Equivalent

Aristo Medical Products, Inc.

FDA 510(k) clearance K960251 for COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR, Substantially Equivalent on 1996-03-26. Applicant: Aristo Medical Products, Inc..

Clearance details

Applicant: Aristo Medical Products, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 1996-01-18
Decision date: 1996-03-26
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.