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 Reduced- Montage Standard Electroencephalograph
510(k) Number K024245
Device Name ENVOY PATIENT MONITOR
Applicant
MENNEN MEDICAL LTD.
4 HAYARDEN ST., YAVNE
P.O. BOX 102
REHOVOT,  IL 76100
Applicant Contact EREZ NIMROD
Correspondent
MENNEN MEDICAL LTD.
4 HAYARDEN ST., YAVNE
P.O. BOX 102
REHOVOT,  IL 76100
Correspondent Contact EREZ NIMROD
Regulation Number882.1400
Classification Product Code
OMC  
Date Received12/23/2002
Decision Date 05/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-