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FDA 510(k)

MAGPRO, MODEL R30

K-Number: K061645 · 2006-10-31

ApplicantTonica Elektronik A/S
Decision Date2006-10-31
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MAGPRO, MODEL R30 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 2006-10-31 under 510(k) number K061645. 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, MODEL R30?

MAGPRO, MODEL R30 is a medical device that received FDA 510(k) clearance on 2006-10-31. The listed applicant is Tonica Elektronik A/S. The 510(k) number is K061645.

When did MAGPRO, MODEL R30 receive FDA 510(k) clearance?

MAGPRO, MODEL R30 received FDA 510(k) clearance on 2006-10-31, under 510(k) number K061645.

Who is the listed applicant for MAGPRO, MODEL R30?

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, MODEL R30?

The FDA product code for MAGPRO, MODEL R30 is GWF.

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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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