BTL-99-OC— 510(k) K230657
Substantially EquivalentBTL Industries, Inc.
FDA 510(k) clearance K230657 for BTL-99-OC, Substantially Equivalent on 2024-02-01. Applicant: BTL Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- BTL Industries, Inc.
- 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
- Marlborough, MA, US
Recent devices under product code QCI
view all- K243459 — Ultimate rTMS for OCD (M-series)
- K233742 — CloudTMS Edge for OCD
- K231350 — OCD MT Cap (85-00397-000)
- K221129 — CloudTMS for OCD
- 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 BTL Industries, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.