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, Biofeedback
510(k) Number K951213
Device Name RELAXPLUS
Applicant
Ultramind International , Ltd.
P.O. Box 1309
88112
Eilat,  IL 88112
Applicant Contact EMANUEL A ROSEN
Correspondent
Ultramind International , Ltd.
P.O. Box 1309
88112
Eilat,  IL 88112
Correspondent Contact EMANUEL A ROSEN
Regulation Number882.5050
Classification Product Code
HCC  
Date Received03/17/1995
Decision Date 09/20/1995
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
-
-