Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
FDA 510(k) clearance K170141 · decided 2017-05-02
Clearance details
- K-number
- K170141
- Device name
- Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
- Applicant
- Stimwave Technologies Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2017-01-17
- Decision date
- 2017-05-02
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- GZB
- Device class
- 2
- Regulation number
- 882.5880
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Fort Lauderdale, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Stimwave Technologies Incorporated
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.
Recalls involving this device
No recalls on record reference this clearance.