510(k) K191701
K191701 is an FDA 510(k) premarket notification submitted by Mri Interventions, Inc. for the device "Arcus Head Fixation Frame". The FDA issued a decision of Substantially Equivalent on November 15, 2019. The device falls under product code HBL (Holder, Head, Neurosurgical (Skull Clamp)), a Class II device regulated under 21 CFR 882.4460. Mri Interventions, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 15, 2019
- Date Received
- June 25, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Holder, Head, Neurosurgical (Skull Clamp)
- Device Class
- Class II
- Regulation Number
- 882.4460
- Review Panel
- NE
- Submission Type