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FDA 510(k)

AXION 5, MODIFICATION

K-Number: K911814 · 1991-10-15

ApplicantVentura Medical Electronics
Decision Date1991-10-15
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AXION 5, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Ventura Medical Electronics. It received FDA 510(k) clearance on 1991-10-15 under 510(k) number K911814. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXION 5, MODIFICATION?

AXION 5, MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-10-15. The listed applicant is Ventura Medical Electronics. The 510(k) number is K911814.

When did AXION 5, MODIFICATION receive FDA 510(k) clearance?

AXION 5, MODIFICATION received FDA 510(k) clearance on 1991-10-15, under 510(k) number K911814.

Who is the listed applicant for AXION 5, MODIFICATION?

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

What is the FDA product code for AXION 5, MODIFICATION?

The FDA product code for AXION 5, MODIFICATION is GZJ.

Related Clinical Trials

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Other records listing Ventura Medical Electronics 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.

K862602AXION IV GOLDLINE SERIES

Related Devices (Code: GZJ)

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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