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 amplitude-integrated electroencephalograph
510(k) Number K031149
Device Name OLYMPIC CFM 6000
Applicant
OLYMPIC MEDICAL CORP.
5900 FIRST AVE., SOUTH
SEATTLE,  WA  98108
Applicant Contact EDWARD B. (TED) WEILER
Correspondent
OLYMPIC MEDICAL CORP.
5900 FIRST AVE., SOUTH
SEATTLE,  WA  98108
Correspondent Contact EDWARD B. (TED) WEILER
Regulation Number882.1400
Classification Product Code
OMA  
Subsequent Product Code
OMC  
Date Received04/10/2003
Decision Date 05/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-