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 Oximeter, Tissue Saturation
510(k) Number K163472
Device Name Intra.Ox Handheld Tissue Oximeter
Applicant
Vioptix, Inc.
39655 Eureka Dr.
Newark,  CA  94560
Applicant Contact Mark Lonsinger
Correspondent
ViOptix, Inc.
39655 Eureka Dr.
Newark,  CA  94560
Correspondent Contact Mark Lonsinger
Regulation Number870.2700
Classification Product Code
MUD  
Date Received12/12/2016
Decision Date 11/16/2017
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
-
-