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FDA 510(k)

OCUSYSTEM ART ADVANTAGE, MODEL 995

K-Number: K991852 · 1999-07-07

ApplicantSurgical Design Corp.
Decision Date1999-07-07
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OCUSYSTEM ART ADVANTAGE, MODEL 995 is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Design Corp.. It received FDA 510(k) clearance on 1999-07-07 under 510(k) number K991852. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCUSYSTEM ART ADVANTAGE, MODEL 995?

OCUSYSTEM ART ADVANTAGE, MODEL 995 is a medical device that received FDA 510(k) clearance on 1999-07-07. The listed applicant is Surgical Design Corp.. The 510(k) number is K991852.

When did OCUSYSTEM ART ADVANTAGE, MODEL 995 receive FDA 510(k) clearance?

OCUSYSTEM ART ADVANTAGE, MODEL 995 received FDA 510(k) clearance on 1999-07-07, under 510(k) number K991852.

Who is the listed applicant for OCUSYSTEM ART ADVANTAGE, MODEL 995?

The FDA 510(k) record lists Surgical Design Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OCUSYSTEM ART ADVANTAGE, MODEL 995?

The FDA product code for OCUSYSTEM ART ADVANTAGE, MODEL 995 is HQC.

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.

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Other records listing Surgical Design Corp. 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.

K961243OCUSYSTEM ART ADVANTAGEK934817SURGICAL DESIGN CORPORATION MODEL 700 LOW PRESSURE MATTRESS

Related Devices (Code: HQC)

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

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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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