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
510(k) Number K933143
Device Name MODEL ELI 300 ELECTROCARDIOGRAPH
Applicant
Mortara Instrument, Inc.
7865 N. 86th St.
Milwaukee,  WI  53224
Applicant Contact JIM HEADRICK
Correspondent
Mortara Instrument, Inc.
7865 N. 86th St.
Milwaukee,  WI  53224
Correspondent Contact JIM HEADRICK
Classification Product Code
LOS
Date Received06/28/1993
Decision Date 04/15/1994
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-