• 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, muscle monitoring
510(k) Number K981563
Device Name BIOPAK MEASUREMENT SYSTEM
Applicant
BIO-RESEARCH ASSOCIATES, INC.
4113 NORTH PORT WASHINGTON RD.
MILWAUKEE,  WI  53212
Correspondent
BIO-RESEARCH ASSOCIATES, INC.
4113 NORTH PORT WASHINGTON RD.
MILWAUKEE,  WI  53212
Regulation Number890.1375
Classification Product Code
KZM  
Subsequent Product Codes
NFQ   NFS  
Date Received05/01/1998
Decision Date 09/15/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-