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FDA 510(k)

FUKUDA DENSHI MODEL FX-3101

K-Number: K901817 · 1990-08-23

ApplicantFukuda Denshi USA, Inc.
Decision Date1990-08-23
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FUKUDA DENSHI MODEL FX-3101 is the device name listed in this FDA 510(k) record. The listed applicant is Fukuda Denshi USA, Inc.. It received FDA 510(k) clearance on 1990-08-23 under 510(k) number K901817. 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 MODEL FX-3101?

FUKUDA DENSHI MODEL FX-3101 is a medical device that received FDA 510(k) clearance on 1990-08-23. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K901817.

When did FUKUDA DENSHI MODEL FX-3101 receive FDA 510(k) clearance?

FUKUDA DENSHI MODEL FX-3101 received FDA 510(k) clearance on 1990-08-23, under 510(k) number K901817.

Who is the listed applicant for FUKUDA DENSHI MODEL FX-3101?

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

What is the FDA product code for FUKUDA DENSHI MODEL FX-3101?

The FDA product code for FUKUDA DENSHI MODEL FX-3101 is DPS.

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Other records listing Fukuda Denshi USA, Inc. as applicant

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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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