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, physiological, patient(with arrhythmia detection or alarms)
510(k) Number K151027
Device Name zensor system
Applicant
INTELESENS LIMITED
17 HERON ROAD
belfast,  GB bt3 9le
Applicant Contact patricia pepper
Correspondent
PROMEDIC, INC.
24301 WOODSAGE DRIVE
bonita springs,  FL  34134 -2958
Correspondent Contact paul dryden
Regulation Number870.1025
Classification Product Code
MHX  
Date Received04/17/2015
Decision Date 10/02/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-