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 K010422
Device Name ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER
Applicant
INNERSPACE, INC.
2933 SOUTH PULLMAN ST.,
SUITE A
SANTA ANA,  CA  92705
Applicant Contact DONALD E BOBO
Correspondent
INNERSPACE, INC.
2933 SOUTH PULLMAN ST.,
SUITE A
SANTA ANA,  CA  92705
Correspondent Contact DONALD E BOBO
Regulation Number882.1620
Classification Product Code
GWM  
Date Received02/12/2001
Decision Date 06/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-