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 Display, Cathode-Ray Tube, Medical
510(k) Number K212003
Device Name ESSENZ Patient Monitor
Applicant
Livanova Deutschland, GmbH
Lindberghstr. 25
Munich,  DE 80939
Applicant Contact Florian Goetz
Correspondent
Livanova Deutschland, GmbH
Lindberghstr. 25
Munich,  DE 80939
Correspondent Contact Florian Goetz
Regulation Number870.2450
Classification Product Code
DXJ  
Date Received06/28/2021
Decision Date 11/10/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-