510(k) K252821— Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)

Substantially Equivalent

Philips Medizin Systeme Böblingen GmbH

Clearance details

Applicant: Philips Medizin Systeme Böblingen GmbH
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2025-09-04
Decision date: 2026-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Böblingen, DE

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.