510(k) K151354
K151354 is an FDA 510(k) premarket notification submitted by Blackrock Neuromed for the device "Cervello STIM". The FDA issued a decision of Substantially Equivalent on January 27, 2016. The device falls under product code GYC (Electrode, Cortical), a Class II device regulated under 21 CFR 882.1310. Blackrock Neuromed has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 2016
- Date Received
- May 20, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Cortical
- Device Class
- Class II
- Regulation Number
- 882.1310
- Review Panel
- NE
- Submission Type