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FDA 510(k)

FUKUDA DENSHI CARDIMAX FK-11

K-Number: K813023 · 1981-12-02

ApplicantBrentwood Instruments, Inc.
Decision Date1981-12-02
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FUKUDA DENSHI CARDIMAX FK-11 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 1981-12-02 under 510(k) number K813023. The device is classified under product code DSP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUKUDA DENSHI CARDIMAX FK-11?

FUKUDA DENSHI CARDIMAX FK-11 is a medical device that received FDA 510(k) clearance on 1981-12-02. The listed applicant is Brentwood Instruments, Inc.. The 510(k) number is K813023.

When did FUKUDA DENSHI CARDIMAX FK-11 receive FDA 510(k) clearance?

FUKUDA DENSHI CARDIMAX FK-11 received FDA 510(k) clearance on 1981-12-02, under 510(k) number K813023.

Who is the listed applicant for FUKUDA DENSHI CARDIMAX FK-11?

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 FK-11?

The FDA product code for FUKUDA DENSHI CARDIMAX FK-11 is DSP.

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Other records listing Brentwood Instruments, 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.

K896924SPIROSCAN 4000K882366RHYTHMSCAN HR HOLTER RECORDERK871572RHYTHMSCANK860024FUKUDA DENSHI CARDIMAX FCP-211K853979CARDIMAX FX-1164K854505CARDIMAX FX-406U

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Related Devices (Code: DSP)

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.

K250542AC3™ Range™ Intra-Aortic Balloon PumpArrow International, LLCK232343AC3™ Series IABPArrow International, LLCK201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc.K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitArrow International, Inc.K192238AC3 Series Intra-Aortic Balloon Pump (IABP)Arrow International, TeleflexK190101UltraFlex IABArrow International, Inc.

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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