• 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 K102239
Device Name CARESCAPE MONITOR B650
Applicant
GE HEALTHCARE FINLAND OY
KUORTANEENKATU 2
HELSINKI,  FI FIN-00510
Applicant Contact PAIVI ROIHA
Correspondent
GE HEALTHCARE FINLAND OY
KUORTANEENKATU 2
HELSINKI,  FI FIN-00510
Correspondent Contact PAIVI ROIHA
Regulation Number870.1025
Classification Product Code
MHX  
Date Received08/09/2010
Decision Date 10/18/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-