510(k) K072379

MPS OXIPORT AND MPS OXIPORT PLUS by Innerspace, Inc. — Product Code GWM

K072379 is an FDA 510(k) premarket notification submitted by Innerspace, Inc. for the device "MPS OXIPORT AND MPS OXIPORT PLUS". The FDA issued a decision of Substantially Equivalent on April 29, 2008. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Innerspace, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2008
Date Received
August 24, 2007
Clearance Type
Special
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