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 K223574
Device Name IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)
Applicant
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard-Strasse 2
Böblingen,  DE 71034
Applicant Contact Siegfried Breitling
Correspondent
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard-Strasse 2
Böblingen,  DE 71034
Correspondent Contact Siegfried Breitling
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
BZC   BZQ   CBQ   CBR   CBS  
CCK   CCL   DPS   DQA   DRT   DSF  
DSJ   DSK   DXN   FLL   GWQ   GWS  
KLK   KOI   LKD   MLD   MSX   NHO  
NHP   NHQ  
Date Received11/30/2022
Decision Date 08/22/2023
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
-
-