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 K883358
Device Name TELESCAN INSTANT MEMORY ECG RECORDER MODEL T-35CM
Applicant
Telescan Medical Systems
10091 St.Er Rd.
Auburn,  CA  95003
Applicant Contact STANLEY WEGNER
Correspondent
Telescan Medical Systems
10091 St.Er Rd.
Auburn,  CA  95003
Correspondent Contact STANLEY WEGNER
Regulation Number870.2920
Classification Product Code
DXH  
Date Received08/09/1988
Decision Date 10/13/1988
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
-
-