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 K251702
Device Name IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 )
Applicant
Philips Medizin Systeme Böblingen GmbH
Hewlett-Packard-Str. 2
Böblingen,  DE 71034
Applicant Contact Alicia Honemeyer
Correspondent
Philips Medizin Systeme Böblingen GmbH
Hewlett-Packard-Str. 2
Böblingen,  DE 71034
Correspondent Contact Alicia Honemeyer
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
BZC   BZQ   CBQ   CBR   CBS  
CCK   CCL   DPS   DQA   DQK   DRT  
DSF   DSJ   DSK   DXN   FLL   GWQ  
GWS   KLK   KOI   LKD   MLD   MSX  
NHO   NHP   NHQ  
Date Received06/02/2025
Decision Date 11/10/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-