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 Electrode, Electrocardiograph
510(k) Number K840646
Device Name CARDIOTRODE
Applicant
Kholber Corp.
P.O. Box 650490
Miami,  FL  33265
Applicant Contact KEN M KOLBENSCHLAG
Correspondent
Kholber Corp.
P.O. Box 650490
Miami,  FL  33265
Correspondent Contact KEN M KOLBENSCHLAG
Regulation Number870.2360
Classification Product Code
DRX  
Date Received02/15/1984
Decision Date 10/26/1984
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
-
-