FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CloudTMS Edge for OCD
K Number: K233742
·
Decision Dec 22, 2023
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
9
Applicant Total
5
Review Days
30
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Basic Information
- Device Name
- CloudTMS Edge for OCD
- K Number
- K233742
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5802
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Teleemg, LLC
- Date Received
- November 22, 2023
- Decision Date
- December 22, 2023
- Product Code
- QCI
- 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 |
|---|---|---|---|
| QCI | Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder | FDA class 2 | Neurology |
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