FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
K Number: K220127
·
Decision Jul 15, 2022
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
52
Applicant Total
3
Review Days
178
Basic Information
- Device Name
- NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
- K Number
- K220127
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5805
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neuronetics, Inc
- Date Received
- January 18, 2022
- Decision Date
- July 15, 2022
- 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 |
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Other Clearances by Neuronetics, Inc
| K Number | Device Name | ||
|---|---|---|---|
| K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar | May 6, 2022 | Substantially Equivalent |
| K213543 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health | Dec 10, 2021 | Substantially Equivalent |