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 K122333
Device Name MOBILECARE MONITOR
Applicant
Aframe Digital, Inc.
1889 Preston White Dr. Suite 101
Reston,  VA  20191
Applicant Contact JILL THORPE
Correspondent
Aframe Digital, Inc.
1889 Preston White Dr. Suite 101
Reston,  VA  20191
Correspondent Contact JILL THORPE
Regulation Number870.2910
Classification Product Code
DRG  
Date Received08/02/2012
Decision Date 11/19/2012
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
-
-