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FDA 510(k)

MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION

K-Number: K091940 · 2010-03-26

ApplicantTonica Elektronik A/S
Decision Date2010-03-26
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION is the device name listed in this FDA 510(k) record. The listed applicant is Tonica Elektronik A/S. It received FDA 510(k) clearance on 2010-03-26 under 510(k) number K091940. 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 MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION?

MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION is a medical device that received FDA 510(k) clearance on 2010-03-26. The listed applicant is Tonica Elektronik A/S. The 510(k) number is K091940.

When did MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION receive FDA 510(k) clearance?

MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION received FDA 510(k) clearance on 2010-03-26, under 510(k) number K091940.

Who is the listed applicant for MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION?

The FDA 510(k) record lists Tonica Elektronik A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION?

The FDA product code for MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION is GWF.

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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.

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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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