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FDA 510(k)

FUKUDA DENSHI FX-102 AUTO-SINGLE CHAN

K-Number: K833593 · 1984-05-09

ApplicantBrentwood Instruments, Inc.
Decision Date1984-05-09
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FUKUDA DENSHI FX-102 AUTO-SINGLE CHAN 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 1984-05-09 under 510(k) number K833593. 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 FUKUDA DENSHI FX-102 AUTO-SINGLE CHAN?

FUKUDA DENSHI FX-102 AUTO-SINGLE CHAN is a medical device that received FDA 510(k) clearance on 1984-05-09. The listed applicant is Brentwood Instruments, Inc.. The 510(k) number is K833593.

When did FUKUDA DENSHI FX-102 AUTO-SINGLE CHAN receive FDA 510(k) clearance?

FUKUDA DENSHI FX-102 AUTO-SINGLE CHAN received FDA 510(k) clearance on 1984-05-09, under 510(k) number K833593.

Who is the listed applicant for FUKUDA DENSHI FX-102 AUTO-SINGLE CHAN?

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 FX-102 AUTO-SINGLE CHAN?

The FDA product code for FUKUDA DENSHI FX-102 AUTO-SINGLE CHAN 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-211K853979CARDIMAX FX-1164K854505CARDIMAX FX-406U

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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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