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FDA 510(k)

INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN

K-Number: K111098 · 2011-05-27

ApplicantImaging Dynamics Company , Ltd.
Decision Date2011-05-27
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Dynamics Company , Ltd.. It received FDA 510(k) clearance on 2011-05-27 under 510(k) number K111098. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN?

INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN is a medical device that received FDA 510(k) clearance on 2011-05-27. The listed applicant is Imaging Dynamics Company , Ltd.. The 510(k) number is K111098.

When did INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN receive FDA 510(k) clearance?

INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN received FDA 510(k) clearance on 2011-05-27, under 510(k) number K111098.

Who is the listed applicant for INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN?

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

What is the FDA product code for INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN?

The FDA product code for INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN is MQB.

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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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