• 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 K921485
Device Name LA MONT VIDEO PATIENT MONITORING SYSTEM
Applicant
MEDICAL SYSTEMS CORP.
SUITE 20/303 PACIFIC HIGHWAY
P.O. BOX 4O4, LINDFIELD
NWW 2070 AUSTRALIA,  AT
Applicant Contact TONY MONTGOMERY
Correspondent
MEDICAL SYSTEMS CORP.
SUITE 20/303 PACIFIC HIGHWAY
P.O. BOX 4O4, LINDFIELD
NWW 2070 AUSTRALIA,  AT
Correspondent Contact TONY MONTGOMERY
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received03/30/1992
Decision Date 10/22/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-