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 Shunt, Central Nervous System And Components
510(k) Number K123554
Device Name SHUNTCHECK
Applicant
Neurodx Development, LLC
3333 St. Rd.
Suite 210
Bensalem,  PA  19020
Applicant Contact FREDERICK J FRITZ
Correspondent
Neurodx Development, LLC
3333 St. Rd.
Suite 210
Bensalem,  PA  19020
Correspondent Contact FREDERICK J FRITZ
Regulation Number882.5550
Classification Product Code
JXG  
Date Received11/19/2012
Decision Date 03/07/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT00583336
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-