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 Analyzer, Pacemaker Generator Function, Indirect
510(k) Number K870909
Device Name PACEMAKER FUNCTION ANALYZER
Applicant
Paceart, Inc.
159 Millburn Ave.
Millburn,  NJ  07041
Applicant Contact MICHAEL BERGELSON
Correspondent
Paceart, Inc.
159 Millburn Ave.
Millburn,  NJ  07041
Correspondent Contact MICHAEL BERGELSON
Regulation Number870.3640
Classification Product Code
KRE  
Date Received03/05/1987
Decision Date 04/27/1987
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
-
-