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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Electronic
510(k) Number K223785
Device Name N9+
Applicant
Nonagon , Ltd.
1 Haeshel St.
Caesarea,  IL 3079830
Applicant Contact Orly Maor
Correspondent
Hogan Lovells US Lpp
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact Jonathan Kahan
Regulation Number870.1875
Classification Product Code
DQD  
Subsequent Product Codes
DQA   FLL  
Date Received12/16/2022
Decision Date 04/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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