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, Monitoring, Intracranial Pressure
510(k) Number K844566
Device Name ICP MONITOR MODEL 1000
Applicant
Advanced Ultrasonic Testing & Research Corp.
4305-40 Enterprise Dr.
Suite A
Winston-Salem,  NC  27106
Applicant Contact ROBERT P BRINKLEY
Correspondent
Advanced Ultrasonic Testing & Research Corp.
4305-40 Enterprise Dr.
Suite A
Winston-Salem,  NC  27106
Correspondent Contact ROBERT P BRINKLEY
Regulation Number882.1620
Classification Product Code
GWM  
Date Received11/23/1984
Decision Date 08/16/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-