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 K984150
Device Name PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER
Applicant
Ep Medsystems
Cooper Run Executive Park
575 Rt. 73 N., Bldg. D
West Berlin,  NJ  08091
Applicant Contact JOSEPH C GRIFFIN, III
Correspondent
Ep Medsystems
Cooper Run Executive Park
575 Rt. 73 N., Bldg. D
West Berlin,  NJ  08091
Correspondent Contact JOSEPH C GRIFFIN, III
Regulation Number870.1220
Classification Product Code
DRF  
Date Received11/19/1998
Decision Date 02/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-