510(k) K914735

VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM by Camino Laboratories, Inc. — Product Code GWM

K914735 is an FDA 510(k) premarket notification submitted by Camino Laboratories, Inc. for the device "VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM". The FDA issued a decision of Substantially Equivalent on January 17, 1992. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Camino Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1992
Date Received
October 21, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Monitoring, Intracranial Pressure
Device Class
Class II
Regulation Number
882.1620
Review Panel
NE
Submission Type