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FDA 510(k)

INTEGRE, MODEL LP581

K-Number: K080423 · 2008-03-11

ApplicantEllex Medical Pty, Ltd.
Decision Date2008-03-11
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

INTEGRE, MODEL LP581 is the device name listed in this FDA 510(k) record. The listed applicant is Ellex Medical Pty, Ltd.. It received FDA 510(k) clearance on 2008-03-11 under 510(k) number K080423. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRE, MODEL LP581?

INTEGRE, MODEL LP581 is a medical device that received FDA 510(k) clearance on 2008-03-11. The listed applicant is Ellex Medical Pty, Ltd.. The 510(k) number is K080423.

When did INTEGRE, MODEL LP581 receive FDA 510(k) clearance?

INTEGRE, MODEL LP581 received FDA 510(k) clearance on 2008-03-11, under 510(k) number K080423.

Who is the listed applicant for INTEGRE, MODEL LP581?

The FDA 510(k) record lists Ellex Medical Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTEGRE, MODEL LP581?

The FDA product code for INTEGRE, MODEL LP581 is HQF.

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Other records listing Ellex Medical Pty, Ltd. 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: HQF)

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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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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