Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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 St., Suite 201
Los Altos,  CA  94022
Applicant Contact ARTIE KAUSHIK
Correspondent
Gauss Surgical, Inc.,
334 State St., 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
Predetermined Change
Control Plan Authorized		 No
-
-