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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 K252821
Device Name Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)
Applicant
Philips Medizin Systeme Böblingen GmbH
Hewlett-Packard-Strasse 2
Böblingen,  DE 71034
Applicant Contact Nicole Söder
Correspondent
Philips Medizin Systeme Böblingen GmbH
Hewlett-Packard-Strasse 2
Böblingen,  DE 71034
Correspondent Contact Nicole Söder
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/04/2025
Decision Date 05/29/2026
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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