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 Recorder, Paper Chart
510(k) Number K910871
Device Name EDENTEC DIGITAL CHARTER MODEL 3710
Applicant
Edentec Corp.
10252 Valley View Rd.
Eden Prairie,  MN  55344
Applicant Contact Gary Syring
Correspondent
Edentec Corp.
10252 Valley View Rd.
Eden Prairie,  MN  55344
Correspondent Contact Gary Syring
Regulation Number870.2810
Classification Product Code
DSF  
Date Received03/01/1991
Decision Date 08/29/1991
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
-
-