510(k) K172892
K172892 is an FDA 510(k) premarket notification submitted by Headsense Medical, Inc. for the device "Neuro Assessment System NAS-1000". The FDA issued a decision of Substantially Equivalent on March 8, 2018. The device falls under product code QBE (Cranial Sound Monitor), a Class II device regulated under 21 CFR 870.1875.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 2018
- Date Received
- September 22, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cranial Sound Monitor
- Device Class
- Class II
- Regulation Number
- 870.1875
- Review Panel
- NE
- Submission Type
To non-invasively detect, monitor, record and display acoustic signals in the brain.