Neuro Assessment System NAS-1000
FDA 510(k) clearance K172892 · decided 2018-03-08
Clearance details
- K-number
- K172892
- Device name
- Neuro Assessment System NAS-1000
- Applicant
- Headsense Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-09-22
- Decision date
- 2018-03-08
- Days to decision
- 167 days
- Clearance type
- Traditional
- Product code
- QBE
- Device class
- 2
- Regulation number
- 870.1875
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Akron, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.