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FDA 510(k)

AXIOM-HVG

K-Number: K955146 · 1996-05-17

ApplicantAxiom Manufacturing
Decision Date1996-05-17
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

AXIOM-HVG is the device name listed in this FDA 510(k) record. The listed applicant is Axiom Manufacturing. It received FDA 510(k) clearance on 1996-05-17 under 510(k) number K955146. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the AXIOM-HVG?

AXIOM-HVG is a medical device that received FDA 510(k) clearance on 1996-05-17. The listed applicant is Axiom Manufacturing. The 510(k) number is K955146.

When did AXIOM-HVG receive FDA 510(k) clearance?

AXIOM-HVG received FDA 510(k) clearance on 1996-05-17, under 510(k) number K955146.

Who is the listed applicant for AXIOM-HVG?

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

What is the FDA product code for AXIOM-HVG?

The FDA product code for AXIOM-HVG is IPF.

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 Axiom Manufacturing 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.

K964423AXIOM INF

Related Devices (Code: IPF)

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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