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FDA 510(k)

AXIOM NVP8500

K-Number: K051135 · 2005-08-11

ApplicantAxiom Worldwide, Inc.
Decision Date2005-08-11
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AXIOM NVP8500 is the device name listed in this FDA 510(k) record. The listed applicant is Axiom Worldwide, Inc.. It received FDA 510(k) clearance on 2005-08-11 under 510(k) number K051135. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXIOM NVP8500?

AXIOM NVP8500 is a medical device that received FDA 510(k) clearance on 2005-08-11. The listed applicant is Axiom Worldwide, Inc.. The 510(k) number is K051135.

When did AXIOM NVP8500 receive FDA 510(k) clearance?

AXIOM NVP8500 received FDA 510(k) clearance on 2005-08-11, under 510(k) number K051135.

Who is the listed applicant for AXIOM NVP8500?

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

What is the FDA product code for AXIOM NVP8500?

The FDA product code for AXIOM NVP8500 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 Worldwide, Inc. 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.

K060735DRX9000 TRUE SPINAL DECOMPRESSION SYSTEMK050687AXIOM EPS8000K010292DRX 2000

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

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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