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 Transducer, Blood-Pressure, Extravascular
510(k) Number K813266
Device Name NIHON KOHDEN ELECTROCARDIOGRAPH
Applicant
Nihon Kohden America, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Nihon Kohden America, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.2850
Classification Product Code
DRS  
Date Received11/20/1981
Decision Date 01/29/1982
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
-
-