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 Stimulator, Electrical, Transcutaneous, For Arthritis
510(k) Number K983228
Device Name BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000
Applicant
Murray Electronics
260 Schilling Cir.
Hunt Valley,  MD  21031
Applicant Contact KENT C HOFFMAN
Correspondent
Murray Electronics
260 Schilling Cir.
Hunt Valley,  MD  21031
Correspondent Contact KENT C HOFFMAN
Regulation Number882.5890
Classification Product Code
NYN  
Date Received09/15/1998
Decision Date 03/15/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-