510(k) DEN140040
- Device
- Nautilus BrainPulse 1000
- Applicant
- Jan Medical, Inc.
- 510(k) number
- DEN140040
- Product code
- POP
- Decision
- Unknown (DENG)
- Decision date
- 2016-08-01
- Date received
- 2014-12-23
- Regulation
- 882.1630
- Classification name
- Cranial Motion Measurement Device
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Paul Lovoi
- Address
- 110 Pioneer Way, Suite L Mountain View CA US 94041 94041
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code POP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K170926 | BrainPulse 1100 | Jan Medical, Inc. | 2017-04-28 |