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 K130849
Device Name INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450
Applicant
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
HEWLETT-PACKARD STR.2
BOEBLINGEN,  DE D 71034
Applicant Contact MARKUS STACHA
Correspondent
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
HEWLETT-PACKARD STR.2
BOEBLINGEN,  DE D 71034
Correspondent Contact MARKUS STACHA
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
BZC   BZQ   CBQ   CBR   CBS  
CCK   CCL   DPS   DQA   DRJ   DRQ  
DRS   DRT   DRW   DSA   DSB   DSF  
DSH   DSI   DSJ   DSK   DXG   DXN  
FLL   KLK   KRB   KRC   LKD   MLC  
MLD   MSX   NHO   NHP   NHQ  
Date Received03/26/2013
Decision Date 06/14/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-