503 PULSE OXIMETER— 510(k) K911124

Substantially Equivalent

Criticare Systems, Inc.

FDA 510(k) clearance K911124 for 503 PULSE OXIMETER, Substantially Equivalent on 1991-06-07. Applicant: Criticare Systems, Inc..

Clearance details

Applicant: Criticare Systems, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 1991-03-12
Decision date: 1991-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, 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.