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 Heat-Exchanger, Cardiopulmonary Bypass
510(k) Number K873561
Device Name ELECTROMEDICS D1079E
Applicant
Electromedics, Inc.
P.O. Box 3315
Englewood,  CO  80155
Applicant Contact DENNIS MCELWEE
Correspondent
Electromedics, Inc.
P.O. Box 3315
Englewood,  CO  80155
Correspondent Contact DENNIS MCELWEE
Regulation Number870.4240
Classification Product Code
DTR  
Date Received09/02/1987
Decision Date 11/05/1987
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
-
-