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 Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K854013
Device Name TRANSTELEPHONIC ECG RECORDER/TRANSMITTER & RECEIVE
Applicant
Medrand, Inc.
2376 Madison Rd.
Cincinnati,  OH  45208
Applicant Contact JAMES T GOURZIS
Correspondent
Medrand, Inc.
2376 Madison Rd.
Cincinnati,  OH  45208
Correspondent Contact JAMES T GOURZIS
Regulation Number870.2920
Classification Product Code
DXH  
Date Received09/30/1985
Decision Date 02/28/1986
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
-
-