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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
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
Boblingen Gmbh
Hewlett-Packard St. 2
Boblingen,  DE 71034
Applicant Contact Jamie Palmer
Correspondent
Philips Medizin Systeme
Boblingen Gmbh
Hewlett-Packard St. 2
Boblingen,  DE 71034
Correspondent Contact Jamie Palmer
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/04/2025
Decision Date 05/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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