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 K853058
Device Name NEOS - M ABP
Applicant
Biotronik Sales, Inc.
Post Office Box 1988
Lake Oswego,  OR  97034
Applicant Contact CAWTHON
Correspondent
Biotronik Sales, Inc.
Post Office Box 1988
Lake Oswego,  OR  97034
Correspondent Contact CAWTHON
Regulation Number870.3610
Classification Product Code
DXY  
Date Received07/19/1985
Decision Date 09/13/1985
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
-
-