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 Pulse-Generator, Pacemaker, External
510(k) Number K821791
Device Name EXTERNAL PULSE GENERATOR - EV4542
Applicant
AMERICAN PACEMAKER CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
AMERICAN PACEMAKER CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.3600
Classification Product Code
DTE  
Date Received06/17/1982
Decision Date 07/06/1982
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
-
-