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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplifier, Physiological Signal
510(k) Number K260648
Device Name PolySense
Applicant
Itamar Medical , Ltd.
9 Halamish St.
Caesarea,  IL 3088900
Applicant Contact Dafna Raiman
Correspondent
Hogan Lovells US LLP
555 13 St. NW
Washington,  DC  20004
Correspondent Contact John Smith
Regulation Number882.1835
Classification Product Code
GWL  
Subsequent Product Code
DSH  
Date Received02/27/2026
Decision Date 10/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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