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 K921929
Device Name GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION)
Applicant
General Devices
190 Leonia Ave.
Bogota,  NJ  07603
Applicant Contact MICHAEL SMITH
Correspondent
General Devices
190 Leonia Ave.
Bogota,  NJ  07603
Correspondent Contact MICHAEL SMITH
Regulation Number870.2920
Classification Product Code
DXH  
Date Received04/24/1992
Decision Date 09/18/1992
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
-
-