510(k) K141368
K141368 is an FDA 510(k) premarket notification submitted by NeuroPace, Inc. for the device "NEUROPACE BURR HOLE COVER". The FDA issued a decision of Substantially Equivalent on July 11, 2014. The device falls under product code GXR (Cover, Burr Hole), a Class II device regulated under 21 CFR 882.5250. NeuroPace, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 2014
- Date Received
- May 23, 2014
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cover, Burr Hole
- Device Class
- Class II
- Regulation Number
- 882.5250
- Review Panel
- NE
- Submission Type