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FDA 510(k)

ENDOMED CV405

K-Number: K880699 · 1988-05-02

ApplicantHenley Intl.
Decision Date1988-05-02
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ENDOMED CV405 is the device name listed in this FDA 510(k) record. The listed applicant is Henley Intl.. It received FDA 510(k) clearance on 1988-05-02 under 510(k) number K880699. 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 ENDOMED CV405?

ENDOMED CV405 is a medical device that received FDA 510(k) clearance on 1988-05-02. The listed applicant is Henley Intl.. The 510(k) number is K880699.

When did ENDOMED CV405 receive FDA 510(k) clearance?

ENDOMED CV405 received FDA 510(k) clearance on 1988-05-02, under 510(k) number K880699.

Who is the listed applicant for ENDOMED CV405?

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

What is the FDA product code for ENDOMED CV405?

The FDA product code for ENDOMED CV405 is IPF.

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Other records listing Henley Intl. as applicant

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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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