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 K001433
Device Name CNS-9300 SERIES CENTRAL STATION
Applicant
Nihon Kohden America, Inc.
2601 Campus Dr.
Irvine,  CA  92612 -1601
Applicant Contact BONNIE BISHOP
Correspondent
Nihon Kohden America, Inc.
2601 Campus Dr.
Irvine,  CA  92612 -1601
Correspondent Contact BONNIE BISHOP
Regulation Number870.1025
Classification Product Code
MHX  
Date Received05/08/2000
Decision Date 11/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-