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FDA 510(k)

CARDIMAX FX-1164

K-Number: K853979 · 1986-02-06

ApplicantBrentwood Instruments, Inc.
Decision Date1986-02-06
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIMAX FX-1164 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 1986-02-06 under 510(k) number K853979. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIMAX FX-1164?

CARDIMAX FX-1164 is a medical device that received FDA 510(k) clearance on 1986-02-06. The listed applicant is Brentwood Instruments, Inc.. The 510(k) number is K853979.

When did CARDIMAX FX-1164 receive FDA 510(k) clearance?

CARDIMAX FX-1164 received FDA 510(k) clearance on 1986-02-06, under 510(k) number K853979.

Who is the listed applicant for CARDIMAX FX-1164?

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-1164?

The FDA product code for CARDIMAX FX-1164 is DPS.

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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-211K854505CARDIMAX FX-406UK851135SPIRO SCAN

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Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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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