StimRouter Neuromodulation System
FDA 510(k) clearance K200482 · decided 2020-03-27
Clearance details
- K-number
- K200482
- Device name
- StimRouter Neuromodulation System
- Applicant
- Bioness, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-02-27
- Decision date
- 2020-03-27
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- GZF
- Device class
- 2
- Regulation number
- 882.5870
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Valencia, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.