510(k) K801755

MMI/GAELTEC CATHETER TIP PRESSURE by Medical Measurements, Inc. — Product Code GWM

K801755 is an FDA 510(k) premarket notification submitted by Medical Measurements, Inc. for the device "MMI/GAELTEC CATHETER TIP PRESSURE". The FDA issued a decision of Substantially Equivalent on August 13, 1980. 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
August 13, 1980
Date Received
July 28, 1980
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