510(k) K974088
K974088 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Professionals, Inc. for the device "CODMAN INTRACRANIAL BOLT". The FDA issued a decision of Substantially Equivalent on January 9, 1998. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Johnson & Johnson Professionals, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 1998
- Date Received
- October 30, 1997
- 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