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FDA 510(k)

ADVANCED LUNG ANALYSIS II

K-Number: K042694 · 2004-11-18

ApplicantGE Medical Systems
Decision Date2004-11-18
Product CodeOEB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ADVANCED LUNG ANALYSIS II is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 2004-11-18 under 510(k) number K042694. The device is classified under product code OEB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVANCED LUNG ANALYSIS II?

ADVANCED LUNG ANALYSIS II is a medical device that received FDA 510(k) clearance on 2004-11-18. The listed applicant is GE Medical Systems. The 510(k) number is K042694.

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

ADVANCED LUNG ANALYSIS II received FDA 510(k) clearance on 2004-11-18, under 510(k) number K042694.

Who is the listed applicant for ADVANCED LUNG ANALYSIS II?

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

What is the FDA product code for ADVANCED LUNG ANALYSIS II?

The FDA product code for ADVANCED LUNG ANALYSIS II is OEB.

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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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