510(k) K160434
K160434 is an FDA 510(k) premarket notification submitted by Mri Interventions, Inc. for the device "ClearPoint System". The FDA issued a decision of Substantially Equivalent on March 17, 2016. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Mri Interventions, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 2016
- Date Received
- February 16, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neurological Stereotaxic Instrument
- Device Class
- Class II
- Regulation Number
- 882.4560
- Review Panel
- NE
- Submission Type