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FDA 510(k)

AQUILION RXL

K-Number: K121553 · 2012-07-26

ApplicantToshibamedical Systems Corporation
Decision Date2012-07-26
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AQUILION RXL is the device name listed in this FDA 510(k) record. The listed applicant is Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2012-07-26 under 510(k) number K121553. 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 RXL?

AQUILION RXL is a medical device that received FDA 510(k) clearance on 2012-07-26. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K121553.

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

AQUILION RXL received FDA 510(k) clearance on 2012-07-26, under 510(k) number K121553.

Who is the listed applicant for AQUILION RXL?

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

What is the FDA product code for AQUILION RXL?

The FDA product code for AQUILION RXL is JAK.

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Other records listing Toshibamedical Systems Corporation as applicant

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Related Devices (Code: 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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