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 Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number K893611
Device Name BARD PLAQUE ELECTRODE ARRAY
Applicant
Bard Electrophysiology
5 Federal St.
P.O. Box 5069
Billerica,  MA  01822
Applicant Contact ERNEST MANFREDO
Correspondent
Bard Electrophysiology
5 Federal St.
P.O. Box 5069
Billerica,  MA  01822
Correspondent Contact ERNEST MANFREDO
Regulation Number870.1220
Classification Product Code
DRF  
Date Received05/10/1989
Decision Date 07/14/1989
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
-
-