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 K001110
Device Name CRYSTAL-EEG MODEL 15
Applicant
Cleveland Medical Devices, Inc.
11000 Cedar Ave., Suite 130
Cleveland,  OH  44106
Applicant Contact ROBERT N SCHMIDT
Correspondent
Cleveland Medical Devices, Inc.
11000 Cedar Ave., Suite 130
Cleveland,  OH  44106
Correspondent Contact ROBERT N SCHMIDT
Regulation Number882.1400
Classification Product Code
OMC  
Date Received04/06/2000
Decision Date 07/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-