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 Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K130676
Device Name AMBIO REMOTE HEALTH MONITORING SYSTEM
Applicant
Arrayent Health, LLC D/B/A Ambio Health
1266 E. Main St.
Suite 700r
Stamford,  CT  06902
Applicant Contact KEVIN JONES
Correspondent
Arrayent Health, LLC D/B/A Ambio Health
1266 E. Main St.
Suite 700r
Stamford,  CT  06902
Correspondent Contact KEVIN JONES
Regulation Number870.2910
Classification Product Code
DRG  
Date Received03/12/2013
Decision Date 07/08/2013
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
-
-