Nautilus BrainPulse 1000
FDA 510(k) clearance DEN140040 · decided 2016-08-01
Clearance details
- K-number
- DEN140040
- Device name
- Nautilus BrainPulse 1000
- Applicant
- Jan Medical, Inc.
- Decision
- Unknown
- Date received
- 2014-12-23
- Decision date
- 2016-08-01
- Days to decision
- 587 days
- Clearance type
- Direct
- Product code
- POP
- Device class
- 2
- Regulation number
- 882.1630
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Jan Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BrainPulse 1100 (K170926) | Jan Medical, Inc. | 2017-04-28 |
Recalls involving this device
No recalls on record reference this clearance.