510(k) K190246
K190246 is an FDA 510(k) premarket notification submitted by Monarch Bioimplants GmbH for the device "NeuroShield". The FDA issued a decision of Substantially Equivalent on May 31, 2019. The device falls under product code JXI (Cuff, Nerve), a Class II device regulated under 21 CFR 882.5275.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 2019
- Date Received
- February 6, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cuff, Nerve
- Device Class
- Class II
- Regulation Number
- 882.5275
- Review Panel
- NE
- Submission Type