510(k) K202174
K202174 is an FDA 510(k) premarket notification submitted by Blackrock Microsystems for the device "Digital NeuroPort Biopotential Signal Processing System". The FDA issued a decision of Substantially Equivalent on February 10, 2021. The device falls under product code GWL (Amplifier, Physiological Signal), a Class II device regulated under 21 CFR 882.1835. Blackrock Microsystems has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 2021
- Date Received
- August 4, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Amplifier, Physiological Signal
- Device Class
- Class II
- Regulation Number
- 882.1835
- Review Panel
- NE
- Submission Type