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FDA 510(k)

INTEGRE PRO, MODEL L2RY

K-Number: K081565 · 2008-07-02

ApplicantEllex Medical Pty, Ltd.
Decision Date2008-07-02
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

INTEGRE PRO, MODEL L2RY 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 2008-07-02 under 510(k) number K081565. 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 PRO, MODEL L2RY?

INTEGRE PRO, MODEL L2RY is a medical device that received FDA 510(k) clearance on 2008-07-02. The listed applicant is Ellex Medical Pty, Ltd.. The 510(k) number is K081565.

When did INTEGRE PRO, MODEL L2RY receive FDA 510(k) clearance?

INTEGRE PRO, MODEL L2RY received FDA 510(k) clearance on 2008-07-02, under 510(k) number K081565.

Who is the listed applicant for INTEGRE PRO, MODEL L2RY?

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 PRO, MODEL L2RY?

The FDA product code for INTEGRE PRO, MODEL L2RY 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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