K253887

Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)

510(k) number
K253887
Device name
Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)
Applicant
Philips Medizin Systeme DE
Product code
DQA — Oximeter
Decision date
2026-05-01
Date received
2025-12-04
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K253887.pdf

Official FDA record: K253887
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.