HORIZON TMS Therapy System with Navigation— 510(k) K183376
Substantially EquivalentMagstim Company, Ltd.
FDA 510(k) clearance K183376 for HORIZON TMS Therapy System with Navigation, Substantially Equivalent on 2019-04-03. Applicant: Magstim Company, Ltd.. Device class: 2.
Clearance details
- Applicant
- Magstim Company, Ltd.
- Product code
- Code OBP
- Device class
- Class 2
- Regulation
- 21 CFR 882.5805
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Whitland, GB
Recent devices under product code OBP
view allMore clearances from Magstim Company, Ltd.
view all- K223154 — Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
- K222171 — Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
- K211389 — Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation
- K203684 — Neurosign V4 Intraoperative Nerve Monitor
- K182853 — HORIZON TMS Therapy System
Adverse events under product code OBP
product code OBP- Injury
- 270
- Total
- 270
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K183376
K-number listed on FDA's recall record- Z-1965-2020 — Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
- Z-1966-2020 — Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183376.
Data sourced from openFDA. This site is unofficial and independent of the FDA.