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
510(k) Number K092117
Device Name SCENAR, MODEL 10
Applicant
RITM OKB ZAO
99, PETROVSKAYA
TAGANROG,  RU 347900
Applicant Contact LARISA SHPUNGINA
Correspondent
RITM OKB ZAO
99, PETROVSKAYA
TAGANROG,  RU 347900
Correspondent Contact LARISA SHPUNGINA
Date Received07/14/2009
Decision Date 05/28/2010
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-