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 K923026
Device Name PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER
Applicant
Biotronik, GmbH & Co.
6024 Southwest Jean Rd.
Unit B4
Lake Oswego,  OR  97035
Applicant Contact STEPHEN K DEOL
Correspondent
Biotronik, GmbH & Co.
6024 Southwest Jean Rd.
Unit B4
Lake Oswego,  OR  97035
Correspondent Contact STEPHEN K DEOL
Regulation Number870.3610
Classification Product Code
DXY  
Date Received06/23/1992
Decision Date 08/19/1993
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
-
-