• 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 calculator, drug dose
510(k) Number K201619
Device Name EndoTool IV System
Monarch Medical Technologies, LLC
4400 Stuart Andrew Blvd, Suite N
Charlotte,  NC  28217
Applicant Contact Ann Marie Gaitan
Medical Device Academy
4400 Stuart Andrew Blvd., Suite N
Charlotte,  NC  28217
Correspondent Contact Ann Marie Gaitan
Regulation Number868.1890
Classification Product Code
Date Received06/15/2020
Decision Date 08/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No