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FDA 510(k)

AXIOM, SUNFAST

K-Number: K944915 · 1994-11-22

ApplicantAxiom Ent. Co., Ltd.
Decision Date1994-11-22
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AXIOM, SUNFAST is the device name listed in this FDA 510(k) record. The listed applicant is Axiom Ent. Co., Ltd.. It received FDA 510(k) clearance on 1994-11-22 under 510(k) number K944915. The device is classified under product code HQY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXIOM, SUNFAST?

AXIOM, SUNFAST is a medical device that received FDA 510(k) clearance on 1994-11-22. The listed applicant is Axiom Ent. Co., Ltd.. The 510(k) number is K944915.

When did AXIOM, SUNFAST receive FDA 510(k) clearance?

AXIOM, SUNFAST received FDA 510(k) clearance on 1994-11-22, under 510(k) number K944915.

Who is the listed applicant for AXIOM, SUNFAST?

The FDA 510(k) record lists Axiom Ent. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AXIOM, SUNFAST?

The FDA product code for AXIOM, SUNFAST is HQY.

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Related Devices (Code: HQY)

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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