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FDA 510(k)

ADVANCED LUNG ANALYSIS-1

K-Number: K013381 · 2001-10-26

ApplicantGeneral Electric Co.
Decision Date2001-10-26
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ADVANCED LUNG ANALYSIS-1 is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 2001-10-26 under 510(k) number K013381. 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 ADVANCED LUNG ANALYSIS-1?

ADVANCED LUNG ANALYSIS-1 is a medical device that received FDA 510(k) clearance on 2001-10-26. The listed applicant is General Electric Co.. The 510(k) number is K013381.

When did ADVANCED LUNG ANALYSIS-1 receive FDA 510(k) clearance?

ADVANCED LUNG ANALYSIS-1 received FDA 510(k) clearance on 2001-10-26, under 510(k) number K013381.

Who is the listed applicant for ADVANCED LUNG ANALYSIS-1?

The FDA 510(k) record lists General Electric Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVANCED LUNG ANALYSIS-1?

The FDA product code for ADVANCED LUNG ANALYSIS-1 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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