510(k) K010422
K010422 is an FDA 510(k) premarket notification submitted by Innerspace, Inc. for the device "ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER". The FDA issued a decision of Substantially Equivalent on June 28, 2001. 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
- June 28, 2001
- Date Received
- February 12, 2001
- 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