• 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 K132930
Device Name MYHEALTHPOINT TELEHEALTH MANAGER
Applicant
ENTRA HEALTH SYSTEMS
3111 Camino Del Rio North
Suite 101
san diego,  CA  92108
Applicant Contact richard strobridge
Correspondent
ENTRA HEALTH SYSTEMS
3111 Camino Del Rio North
Suite 101
san diego,  CA  92108
Correspondent Contact richard strobridge
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Codes
DPS   DQA   DRX   DXN   FLL  
JQP  
Date Received09/18/2013
Decision Date 04/14/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-