510(k) K853864

INTRACRANIAL PRESSURE MONITORING KIT 070 by Camino Laboratories, Inc. — Product Code GWM

K853864 is an FDA 510(k) premarket notification submitted by Camino Laboratories, Inc. for the device "INTRACRANIAL PRESSURE MONITORING KIT 070". The FDA issued a decision of Substantially Equivalent on February 20, 1986. 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
February 20, 1986
Date Received
September 17, 1985
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