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FDA 510(k)

CARDIMAX FX-406U

K-Number: K854505 · 1986-02-04

ApplicantBrentwood Instruments, Inc.
Decision Date1986-02-04
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIMAX FX-406U 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 1986-02-04 under 510(k) number K854505. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIMAX FX-406U?

CARDIMAX FX-406U is a medical device that received FDA 510(k) clearance on 1986-02-04. The listed applicant is Brentwood Instruments, Inc.. The 510(k) number is K854505.

When did CARDIMAX FX-406U receive FDA 510(k) clearance?

CARDIMAX FX-406U received FDA 510(k) clearance on 1986-02-04, under 510(k) number K854505.

Who is the listed applicant for CARDIMAX FX-406U?

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 CARDIMAX FX-406U?

The FDA product code for CARDIMAX FX-406U is DRS.

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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-1164K851135SPIRO SCAN

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Related Devices (Code: DRS)

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.

K254074TruPressProcerus EnterprisesK242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLCK221782Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte. , Ltd.K172458HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K163172HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K161408Compass Cast and MAPCenturion Medical Products Corporation

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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