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 Detector And Alarm, Arrhythmia
510(k) Number K002068
Device Name ORG-9200A
Applicant
Nihon Kohden America, Inc.
90 Icon St.
Foothill,  CA  92610
Applicant Contact BONNIE BISHOP
Correspondent
Nihon Kohden America, Inc.
90 Icon St.
Foothill,  CA  92610
Correspondent Contact BONNIE BISHOP
Regulation Number870.1025
Classification Product Code
DSI  
Date Received07/07/2000
Decision Date 02/08/2001
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
-
-