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FDA 510(k)

MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00

K-Number: K080499 · 2008-12-08

ApplicantThe Magstim Company , Ltd.
Decision Date2008-12-08
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00 is the device name listed in this FDA 510(k) record. The listed applicant is The Magstim Company , Ltd.. It received FDA 510(k) clearance on 2008-12-08 under 510(k) number K080499. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00?

MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00 is a medical device that received FDA 510(k) clearance on 2008-12-08. The listed applicant is The Magstim Company , Ltd.. The 510(k) number is K080499.

When did MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00 receive FDA 510(k) clearance?

MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00 received FDA 510(k) clearance on 2008-12-08, under 510(k) number K080499.

Who is the listed applicant for MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00?

The FDA 510(k) record lists The Magstim Company , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00?

The FDA product code for MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00 is GWF.

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Other records listing The Magstim Company , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232235Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide ProK130403MAGSTIM DOUBLE 70-2 COILK083242NEUROSIGN AVALANCHE MOTOR NERVE MONITORK071349NEUROSIGN LARYNGEAL ELECTRODESK051864MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00K053141NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800

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Related Devices (Code: GWF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbHK253301BraiN20® (BraiN20)Time IS Brain, S.L.K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.K243982Nicolet EDXNatus Neurology IncorporatedK243495Natus Ultrapro S100 (982A0594)Natus Neurology IncorporatedK242345Delphi StimulatorQuantalx Neuroscience

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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