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 Full-Montage Standard Electroencephalograph
510(k) Number K864928
Device Name BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER
Applicant
BIO-SCAN, INC.
1717 S. ERVAY ST.
DALLAS,  TX  75215
Applicant Contact LARRY S GANTT
Correspondent
BIO-SCAN, INC.
1717 S. ERVAY ST.
DALLAS,  TX  75215
Correspondent Contact LARRY S GANTT
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received12/16/1986
Decision Date 03/31/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-