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 K850849
Device Name MYOMETER EMG BIOFEEDBACK DEVICE
Applicant
Physio Technology, Inc.
1925 W. 6th St.
Topeka,  KS  66606
Applicant Contact JAMES G BAUMANN
Correspondent
Physio Technology, Inc.
1925 W. 6th St.
Topeka,  KS  66606
Correspondent Contact JAMES G BAUMANN
Regulation Number882.5050
Classification Product Code
HCC  
Date Received03/01/1985
Decision Date 05/31/1985
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
-
-