510(k) K170926
- Device
- BrainPulse 1100
- Applicant
- Jan Medical, Inc.
- 510(k) number
- K170926
- Product code
- POP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-04-28
- Date received
- 2017-03-29
- Regulation
- 882.1630
- Classification name
- Cranial Motion Measurement Device
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Prabhu Raghavan
- Address
- 110 Pioneer Way, Suite L Mountain View CA US 94041 94041
Source Documents#
Other 510(k) Records For Product Code POP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN140040 | Nautilus BrainPulse 1000 | Jan Medical, Inc. | 2016-08-01 |
Legacy Summary#
summary
FDA Review#
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