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 Device, Monitoring, Intracranial Pressure
510(k) Number K210993
Device Name CereLink ICP Monitor
Applicant
Integra LifeSciences Production Corporation
11 Cabot Boulevard
Mansfield,  MA  02048
Applicant Contact MaryBeth Carson
Correspondent
Integra LifeSciences Production Corporation
11 Cabot Boulevard
Mansfield,  MA  02048
Correspondent Contact MaryBeth Carson
Regulation Number882.1620
Classification Product Code
GWM  
Date Received04/02/2021
Decision Date 04/30/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-