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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Volume
510(k) Number K240706
Device Name PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)
Applicant
Ganshorn Medizin Electronic GmbH
Industriestr 6-8
Niederlauer,  DE D-97618
Applicant Contact Stefan Ponto
Correspondent
Jim Chickering, Regulatory Consultant TO Ganshorn
15 Belleau Woods
Georgetown,  NH  01833
Correspondent Contact Jim Chickering
Regulation Number868.1760
Classification Product Code
JEH  
Subsequent Product Codes
BZG   CAH  
Date Received03/14/2024
Decision Date 12/09/2024
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		 No
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