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 K211294
Device Name Multi-Link X2 ECG Cable and Leadwire System
Applicant
Vyaire Medical, Inc.
26125 N. Riverwoods Blvd.
Mettawa,  IL  60045
Applicant Contact Joshua Davis
Correspondent
Vyaire Medical, Inc.
26125 N. Riverwoods Blvd.
Mettawa,  IL  60045
Correspondent Contact Joshua Davis
Regulation Number870.2900
Classification Product Code
DSA  
Date Received04/28/2021
Decision Date 08/16/2021
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
-
-