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 Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
510(k) Number K932050
Device Name NH-2002
Applicant
New Horizon Health Care
9127 S. 255 W.
Sandy,  UT  84092
Applicant Contact DALE DENSLEY
Correspondent
New Horizon Health Care
9127 S. 255 W.
Sandy,  UT  84092
Correspondent Contact DALE DENSLEY
Regulation Number882.5800
Classification Product Code
QJQ  
Date Received04/27/1993
Decision Date 06/05/1995
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
-
-