510(k) K182967
- Device
- Visor System
- Applicant
- Cerebrotech Medical Systems, Inc.
- 510(k) number
- K182967
- Product code
- QAF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-11-23
- Date received
- 2018-10-26
- Regulation
- 870.2770
- Classification name
- Impedance Plethysmograph, Cranial
- Medical specialty
- Cardiovascular
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Dawnel Scott
- Address
- 1048 Serpentine Ln. Suite 301 Pleasanton CA US 94566 94566
Source Documents#
Other 510(k) Records For Product Code QAF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171186 | Cerebrotech CMS-5000 | Cerebrotech Medical Systems | 2017-12-08 |
Legacy Summary#
summary
FDA Review#
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