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 Implantable Pacemaker Pulse-Generator
510(k) Number K970072
Device Name OPUS S MODEL 4121 AND 4124 PACEMAKERS
Applicant
Ela Medical, Inc.
2950 Xenium Ln. N.
Plymouth,  MN  55441
Applicant Contact CATHERINE G GOBLE
Correspondent
Ela Medical, Inc.
2950 Xenium Ln. N.
Plymouth,  MN  55441
Correspondent Contact CATHERINE G GOBLE
Regulation Number870.3610
Classification Product Code
DXY  
Date Received01/08/1997
Decision Date 08/29/1997
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-