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 Cable, Transducer And Electrode, Patient, (Including Connector)
510(k) Number K001390
Device Name BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES
Applicant
BIOSENSE WEBSTER, INC.
3333 DIAMOND CANYON RD.
DIAMOND BAR,  CA  91765
Applicant Contact MARIA D OCHOA
Correspondent
BIOSENSE WEBSTER, INC.
3333 DIAMOND CANYON RD.
DIAMOND BAR,  CA  91765
Correspondent Contact MARIA D OCHOA
Regulation Number870.2900
Classification Product Code
DSA  
Date Received05/02/2000
Decision Date 07/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-