Ultimate rTMS for OCD (M-series)— 510(k) K243459
Substantially EquivalentBrain Ultimate, Inc.
FDA 510(k) clearance K243459 for Ultimate rTMS for OCD (M-series), Substantially Equivalent on 2025-04-17. Applicant: Brain Ultimate, Inc.. Device class: 2.
Clearance details
- Applicant
- Brain Ultimate, 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
- Alpharetta, GA, US
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More clearances from Brain Ultimate, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.