CloudTMS for OCD— 510(k) K221129
Substantially EquivalentTeleemg, LLC
FDA 510(k) clearance K221129 for CloudTMS for OCD, Substantially Equivalent on 2023-03-10. Applicant: Teleemg, LLC. Device class: 2.
Clearance details
- Applicant
- Teleemg, LLC
- Product code
- Code QCI
- Device class
- Class 2
- Regulation
- 21 CFR 882.5802
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
Recent devices under product code QCI
view all- K243459 — Ultimate rTMS for OCD (M-series)
- K230657 — BTL-99-OC
- K233742 — CloudTMS Edge for OCD
- K231350 — OCD MT Cap (85-00397-000)
- K212289 — NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar
More clearances from Teleemg, LLC
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