Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)— 510(k) K253887

Substantially Equivalent

Philips Medizin Systeme

FDA 510(k) clearance K253887 for Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401), Substantially Equivalent on 2026-05-01. Applicant: Philips Medizin Systeme.

Clearance details

Applicant: Philips Medizin Systeme
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2025-12-04
Decision date: 2026-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boblingen, 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.