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 K980582
Device Name MULTI-LINK CABLE AND LEAD WIRE SYSTEMS
Applicant
Marquette Medical Systems, Inc.
100 Marquette Dr.
Jupiter,  FL  33468
Applicant Contact MICHAEL LAUGHRAN
Correspondent
Marquette Medical Systems, Inc.
100 Marquette Dr.
Jupiter,  FL  33468
Correspondent Contact MICHAEL LAUGHRAN
Regulation Number870.2900
Classification Product Code
DSA  
Date Received02/17/1998
Decision Date 03/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-