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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K242825
Device Name Prenuvo Body Composition
Applicant
Prenuvo
2727 El Camino Real
Redwood City,  CA  94061
Applicant Contact Sam Hashemi
Correspondent
Innolitics
1101 W. 34th St.
#550
Austin,  TX  78705
Correspondent Contact David Giese
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
QIH  
Date Received09/18/2024
Decision Date 01/17/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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