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 K222422
Device Name Polaris Valve Electronic Reading Instrument
Applicant
Sophysa
05 Rue Guy Moquet
Orsay,  FR 91400
Applicant Contact Philippe Negre
Correspondent
Sophysa
05 Rue Guy Moquet
Orsay,  FR 91400
Correspondent Contact Zheng Xue
Regulation Number882.5550
Classification Product Code
JXG  
Date Received08/11/2022
Decision Date 02/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-