510(k) K172892
- Device
- Neuro Assessment System NAS-1000
- Applicant
- HeadSense Medical Inc.
- 510(k) number
- K172892
- Product code
- QBE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-03-08
- Date received
- 2017-09-22
- Regulation
- 870.1875
- Classification name
- Cranial Sound Monitor
- Medical specialty
- Cardiovascular
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Richard A. Lotti
- Address
- 520 S. Main St. Suite 2457 Akron OH US 44311 44311
Source Documents#
Legacy Summary#
summary
FDA Review#
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