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 K925750
Device Name RELAXOMAT
Applicant
Relaxomat, Inc.
C/O Guito & Associates
4214 El Prado Blvd.
Tampa,  FL  33629
Applicant Contact RALPH M GUITO
Correspondent
Relaxomat, Inc.
C/O Guito & Associates
4214 El Prado Blvd.
Tampa,  FL  33629
Correspondent Contact RALPH M GUITO
Regulation Number882.5050
Classification Product Code
HCC  
Date Received11/13/1992
Decision Date 01/31/1995
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
-
-