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 Device, Sleep Assessment
510(k) Number K862766
Device Name EPISON, ALERTING SYSTEM FOR EPILEPTICS
Applicant
ZYGO INDUSTRIES, INC.
P.O. BOX 1008
PORTLAND,  OR  97207 -1008
Applicant Contact LAWRENCE H WEISS
Correspondent
ZYGO INDUSTRIES, INC.
P.O. BOX 1008
PORTLAND,  OR  97207 -1008
Correspondent Contact LAWRENCE H WEISS
Regulation Number882.5050
Classification Product Code
LEL  
Date Received07/22/1986
Decision Date 03/13/1987
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
-
-