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FDA 510(k)

AQUILION PREMIUM

K-Number: K120546 · 2012-06-13

ApplicantToshiba Medical Systems Corporation, Japan
Decision Date2012-06-13
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AQUILION PREMIUM is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba Medical Systems Corporation, Japan. It received FDA 510(k) clearance on 2012-06-13 under 510(k) number K120546. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AQUILION PREMIUM?

AQUILION PREMIUM is a medical device that received FDA 510(k) clearance on 2012-06-13. The listed applicant is Toshiba Medical Systems Corporation, Japan. The 510(k) number is K120546.

When did AQUILION PREMIUM receive FDA 510(k) clearance?

AQUILION PREMIUM received FDA 510(k) clearance on 2012-06-13, under 510(k) number K120546.

Who is the listed applicant for AQUILION PREMIUM?

The FDA 510(k) record lists Toshiba Medical Systems Corporation, Japan as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AQUILION PREMIUM?

The FDA product code for AQUILION PREMIUM is JAK.

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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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