• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name monitor, physiological, patient(with arrhythmia detection or alarms)
510(k) Number K120366
Device Name INTELLIVUE PATIENT MONITOR
Original Applicant
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
hewlett-packard str.2
boeblingen,  DE d 71034
Original Contact markus stacha
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
BZC   BZQ   CBQ   CBR   CBS  
CCK   CCL   DPS   DQA   DRG   DRJ  
DRQ   DRS   DRT   DRW   DSA   DSB  
DSF   DSH   DSI   DSJ   DSK   DXG  
DXN   FLL   GWR   GWS   KLK   KRB  
KRC   LKD   MLC   MLD   MSX   NHO  
NHP   NHQ  
Date Received02/06/2012
Decision Date 07/18/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-