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FDA 510(k)

FUKUDA DENSHI CARDIMAX FCP-211

K-Number: K860024 · 1986-03-31

ApplicantBrentwood Instruments, Inc.
Decision Date1986-03-31
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FUKUDA DENSHI CARDIMAX FCP-211 is the device name listed in this FDA 510(k) record. The listed applicant is Brentwood Instruments, Inc.. It received FDA 510(k) clearance on 1986-03-31 under 510(k) number K860024. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUKUDA DENSHI CARDIMAX FCP-211?

FUKUDA DENSHI CARDIMAX FCP-211 is a medical device that received FDA 510(k) clearance on 1986-03-31. The listed applicant is Brentwood Instruments, Inc.. The 510(k) number is K860024.

When did FUKUDA DENSHI CARDIMAX FCP-211 receive FDA 510(k) clearance?

FUKUDA DENSHI CARDIMAX FCP-211 received FDA 510(k) clearance on 1986-03-31, under 510(k) number K860024.

Who is the listed applicant for FUKUDA DENSHI CARDIMAX FCP-211?

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

What is the FDA product code for FUKUDA DENSHI CARDIMAX FCP-211?

The FDA product code for FUKUDA DENSHI CARDIMAX FCP-211 is DSI.

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Other records listing Brentwood Instruments, Inc. as applicant

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Related Devices (Code: DSI)

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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