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 Full-Montage Standard Electroencephalograph
510(k) Number K180269
Device Name Cadwell Apollo System
Applicant
Cadwell Industries, Inc.
909 North Kellogg Street
Kennewick,  WA  99336
Applicant Contact Alison Hull
Correspondent
Cadwell Industries, Inc.
909 North Kellogg Street
Kennewick,  WA  99336
Correspondent Contact Alison Hull
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Codes
GWE   GWL   OLT   OLV   OMC  
Date Received01/31/2018
Decision Date 07/17/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-