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 K915153
Device Name ESCORT-LINK ARRHYTHMIA OPTION 23L
Applicant
Medical Data Electronics
12720 Wentworth St.
Arleta,  CA  91331
Applicant Contact JIM ROOKS
Correspondent
Medical Data Electronics
12720 Wentworth St.
Arleta,  CA  91331
Correspondent Contact JIM ROOKS
Regulation Number870.1025
Classification Product Code
DSI  
Date Received11/14/1991
Decision Date 04/27/1992
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
-
-