NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1
FDA 510(k) clearance K083538 · decided 2008-12-16
Clearance details
- K-number
- K083538
- Device name
- NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1
- Applicant
- Neuronetics
- Decision
- Substantially Equivalent
- Date received
- 2008-11-28
- Decision date
- 2008-12-16
- Days to decision
- 18 days
- Clearance type
- Special
- Product code
- OBP
- Device class
- 2
- Regulation number
- 882.5805
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Malvern, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NeuroStar TMS Therapy System/SenStar Treatment Link. The SenStar Treatment Link is a singl recall (Z-1421-2009) | Neuronetics, Inc. | 2009-05-27 |