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 monitor, cardiac (incl. cardiotachometer & rate alarm)
510(k) Number K150992
Device Name Vios Monitoring System
Applicant
VIOS MEDICAL, INC.
7300 HUDSON BLVD N, STE 140
ST. PAUL,  MN  55128
Applicant Contact MEGAN GRAHAM
Correspondent
VIOS MEDICAL, INC.
7300 HUDSON BLVD N, STE 140
ST. PAUL,  MN  55128
Correspondent Contact MEGAN GRAHAM
Regulation Number870.2300
Classification Product Code
DRT  
Subsequent Product Codes
DRG   FLL  
Date Received04/15/2015
Decision Date 12/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-