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 K992439
Device Name NORODYN 8000 SEMG SYSTEM, ND-8000
Applicant
MYOTRONICS-NOROMED, INC.
15425 53RD AVE. SOUTH
TUKWILA,  WA  98188
Applicant Contact FRAY ADIB
Correspondent
MYOTRONICS-NOROMED, INC.
15425 53RD AVE. SOUTH
TUKWILA,  WA  98188
Correspondent Contact FRAY ADIB
Regulation Number882.5050
Classification Product Code
HCC  
Date Received07/22/1999
Decision Date 08/13/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-