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 Electrode, Electrocardiograph
510(k) Number K920867
Device Name EME MP3000 MONITORING AND DIAGNOSTIC RESTING ECG
Applicant
Electro Medical Equipment Co., Inc.
2266 Riverside N.
P.O. Box 1806
Baton Rouge,  LA  70821
Applicant Contact LEONARD CARMOUCHE
Correspondent
Electro Medical Equipment Co., Inc.
2266 Riverside N.
P.O. Box 1806
Baton Rouge,  LA  70821
Correspondent Contact LEONARD CARMOUCHE
Regulation Number870.2360
Classification Product Code
DRX  
Date Received02/25/1992
Decision Date 04/10/1992
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
-
-