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FDA 510(k)

ISIRONA MAGELLAN

K-Number: K130707 · 2013-11-20

ApplicantIsirona, LLC
Decision Date2013-11-20
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ISIRONA MAGELLAN is the device name listed in this FDA 510(k) record. The listed applicant is Isirona, LLC. It received FDA 510(k) clearance on 2013-11-20 under 510(k) number K130707. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISIRONA MAGELLAN?

ISIRONA MAGELLAN is a medical device that received FDA 510(k) clearance on 2013-11-20. The listed applicant is Isirona, LLC. The 510(k) number is K130707.

When did ISIRONA MAGELLAN receive FDA 510(k) clearance?

ISIRONA MAGELLAN received FDA 510(k) clearance on 2013-11-20, under 510(k) number K130707.

Who is the listed applicant for ISIRONA MAGELLAN?

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

What is the FDA product code for ISIRONA MAGELLAN?

The FDA product code for ISIRONA MAGELLAN is MSX.

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Related Devices (Code: MSX)

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Official Source

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

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