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FDA 510(k)

AQUILION LB TRITON V4.91

K-Number: K123500 · 2013-05-02

ApplicantToshibamedical Systems Corporation
Decision Date2013-05-02
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AQUILION LB TRITON V4.91 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 2013-05-02 under 510(k) number K123500. 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 LB TRITON V4.91?

AQUILION LB TRITON V4.91 is a medical device that received FDA 510(k) clearance on 2013-05-02. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K123500.

When did AQUILION LB TRITON V4.91 receive FDA 510(k) clearance?

AQUILION LB TRITON V4.91 received FDA 510(k) clearance on 2013-05-02, under 510(k) number K123500.

Who is the listed applicant for AQUILION LB TRITON V4.91?

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 LB TRITON V4.91?

The FDA product code for AQUILION LB TRITON V4.91 is JAK.

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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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