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FDA 510(k)

ADVANTAGE WINDOWS (AW) FUSION

K-Number: K983256 · 1998-12-15

Decision Date1998-12-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ADVANTAGE WINDOWS (AW) FUSION 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 1998-12-15 under 510(k) number K983256. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVANTAGE WINDOWS (AW) FUSION?

ADVANTAGE WINDOWS (AW) FUSION is a medical device that received FDA 510(k) clearance on 1998-12-15. The listed applicant is GE Medical Systems. The 510(k) number is K983256.

When did ADVANTAGE WINDOWS (AW) FUSION receive FDA 510(k) clearance?

ADVANTAGE WINDOWS (AW) FUSION received FDA 510(k) clearance on 1998-12-15, under 510(k) number K983256.

Who is the listed applicant for ADVANTAGE WINDOWS (AW) FUSION?

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 ADVANTAGE WINDOWS (AW) FUSION?

The FDA product code for ADVANTAGE WINDOWS (AW) FUSION is LLZ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing GE Medical Systems as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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