FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Neurosoft TMS (also CloudTMS)
K Number: K173441
·
Decision Dec 13, 2017
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
52
Applicant Total
4
Review Days
37
Basic Information
- Device Name
- Neurosoft TMS (also CloudTMS)
- K Number
- K173441
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5805
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- TeleEMG, LLC
- Date Received
- November 6, 2017
- Decision Date
- December 13, 2017
- 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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