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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Over-The-Counter Device To Assess Risk Of Sleep Apnea
510(k) Number K240929
Device Name Sleep Apnea Notification Feature (SANF)
Applicant
Apple, Inc.
One Apple Park Way
Cupertino,  CA  95014
Applicant Contact Lynda Ikejimba
Correspondent
Apple, Inc.
One Apple Park Way
Cupertino,  CA  95014
Correspondent Contact Lynda Ikejimba
Classification Product Code
QZW  
Date Received04/04/2024
Decision Date 09/13/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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