Neurosign V4 Intraoperative Nerve Monitor— 510(k) K181559
Substantially EquivalentMagstim Company, Ltd.
FDA 510(k) clearance K181559 for Neurosign V4 Intraoperative Nerve Monitor, Substantially Equivalent on 2018-11-09. Applicant: Magstim Company, Ltd.. Device class: 2.
Clearance details
- Applicant
- Magstim Company, Ltd.
- Product code
- Code PDQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.1820
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Whitland, GB
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- K223438 — TELIGEN System Peripheral Motor Nerve Stimulation Indications
- K221821 — ATEC IOM Accessory Instruments
More 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
- K183376 — HORIZON TMS Therapy System with Navigation
Recalls naming K181559
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181559.
Data sourced from openFDA. This site is unofficial and independent of the FDA.