FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEUROSTAR TMS THERAPY SYSTEM
K Number: K130233
·
Decision Apr 30, 2013
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
65
Applicant Total
7
Review Days
90
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Basic Information
- Device Name
- NEUROSTAR TMS THERAPY SYSTEM
- K Number
- K130233
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5805
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neuronetics
- Date Received
- January 30, 2013
- Decision Date
- April 30, 2013
- Product Code
- OBP
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OBP | Transcranial Magnetic Stimulator | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OBP), ordered by most recent decision date.
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SPRY TMS Therapy System (0550)
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BrainsWay Deep TMS System
FDA 510(k)
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Other Clearances by Neuronetics
| K Number | Device Name | ||
|---|---|---|---|
| K233621 | NeuroStar Advanced Therapy System (Version 3.8) | Dec 13, 2023 | Substantially Equivalent |
| K231350 | OCD MT Cap (85-00397-000) | Jun 8, 2023 | Substantially Equivalent |
| K230029 | NeuroStar Advanced Therapy System (Version 3.7) | Apr 4, 2023 | Substantially Equivalent |
| K133408 | NEUROSTAR TMS THERAPY SYSTEM | Mar 28, 2014 | Substantially Equivalent |
| K083538 | NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1 | Dec 16, 2008 | Substantially Equivalent |
| DEN070003 | NEUROSTAR TMS SYSTEM | Oct 7, 2008 | Unknown |