DISPOSABLE SPO2 SENSOR M1134A— 510(k) K091572

Substantially Equivalent

Philips Medizinsysteme Boeblingen GmbH, Cardiac AN

FDA 510(k) clearance K091572 for DISPOSABLE SPO2 SENSOR M1134A, Substantially Equivalent on 2009-09-22. Applicant: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN.

Clearance details

Applicant: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2009-06-02
Decision date: 2009-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boeblingen, Baden-Wuerttemberg, DE

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.