MINOLTA SM-32 OXYGEN SATURATION MONIT— 510(k) K833973

Substantially Equivalent

Marquest Medical Products, Inc.

FDA 510(k) clearance K833973 for MINOLTA SM-32 OXYGEN SATURATION MONIT, Substantially Equivalent on 1984-05-09. Applicant: Marquest Medical Products, Inc..

Clearance details

Applicant: Marquest Medical Products, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 1983-11-16
Decision date: 1984-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, 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.