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 System, Network And Communication, Physiological Monitors
510(k) Number K242750
Device Name Central Station
Applicant
Nihon Kohden Digital Health Solutions, LLC
14 Bunsen
Irvine,  CA  92618
Applicant Contact Arthur Webb
Correspondent
Nihon Kohden Digital Health Solutions, LLC
14 Bunsen
Irvine,  CA  92618
Correspondent Contact Arthur Webb
Regulation Number870.2300
Classification Product Code
MSX  
Subsequent Product Codes
DRQ   MHX   MWI  
Date Received09/12/2024
Decision Date 06/05/2025
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
-
-