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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image Processing Device For Estimation Of External Blood Loss
510(k) Number K160338
Device Name Triton System
Applicant
GAUSS SURGICAL INC.
334 STATE STREET
SUITE 201
LOS ALTOS,  CA  94022
Applicant Contact ARTIE KAUSHIK
Correspondent
GAUSS SURGICAL INC.
334 STATE STREET
SUITE 201
LOS ALTOS,  CA  94022
Correspondent Contact ARTIE KAUSHIK
Regulation Number880.2750
Classification Product Code
PBZ  
Date Received02/08/2016
Decision Date 08/05/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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