510(k) K863479

MODIFIED ICT/B INTRACRANIAL PRESS. TRANS. EPIDURAL by Medical Measurements, Inc. — Product Code GWM

K863479 is an FDA 510(k) premarket notification submitted by Medical Measurements, Inc. for the device "MODIFIED ICT/B INTRACRANIAL PRESS. TRANS. EPIDURAL". The FDA issued a decision of Substantially Equivalent on October 14, 1986. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Medical Measurements, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1986
Date Received
September 9, 1986
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