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FDA 510(k)

LUNG VOLUME ANALYSIS

K-Number: K113715 · 2012-08-17

ApplicantToshibamedical Systems Corporation
Decision Date2012-08-17
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LUNG VOLUME ANALYSIS 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 2012-08-17 under 510(k) number K113715. 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 LUNG VOLUME ANALYSIS?

LUNG VOLUME ANALYSIS is a medical device that received FDA 510(k) clearance on 2012-08-17. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K113715.

When did LUNG VOLUME ANALYSIS receive FDA 510(k) clearance?

LUNG VOLUME ANALYSIS received FDA 510(k) clearance on 2012-08-17, under 510(k) number K113715.

Who is the listed applicant for LUNG VOLUME ANALYSIS?

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 LUNG VOLUME ANALYSIS?

The FDA product code for LUNG VOLUME ANALYSIS 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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