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FDA 510(k)

FUKUDA DENSHI MODEL AU-5001-5003 THERMAL

K-Number: K852487 · 1985-09-19

ApplicantFukuda Denshi USA, Inc.
Decision Date1985-09-19
Product CodeDSF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FUKUDA DENSHI MODEL AU-5001-5003 THERMAL 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 1985-09-19 under 510(k) number K852487. The device is classified under product code DSF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUKUDA DENSHI MODEL AU-5001-5003 THERMAL?

FUKUDA DENSHI MODEL AU-5001-5003 THERMAL is a medical device that received FDA 510(k) clearance on 1985-09-19. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K852487.

When did FUKUDA DENSHI MODEL AU-5001-5003 THERMAL receive FDA 510(k) clearance?

FUKUDA DENSHI MODEL AU-5001-5003 THERMAL received FDA 510(k) clearance on 1985-09-19, under 510(k) number K852487.

Who is the listed applicant for FUKUDA DENSHI MODEL AU-5001-5003 THERMAL?

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 AU-5001-5003 THERMAL?

The FDA product code for FUKUDA DENSHI MODEL AU-5001-5003 THERMAL is DSF.

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Other records listing Fukuda Denshi USA, 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.

K173226CardiMax ElectrocardiographK112521FUKUDA DENSHI VASERA MODEL VS-1500K103134FUKUDA DENSHIK083697FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210MK082656MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNITK081891FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR

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Related Devices (Code: DSF)

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.

K910871EDENTEC DIGITAL CHARTER MODEL 3710Edentec Corp.K912929DASH IVAstro-Med, Inc.K905856MODEL 556 MONITORGe Medical Systems Information TechnologiesK902586GRI LASERGRAPH(TM) ECG PAPERGri Medical Products, Inc.K902230COLORADO COLOR IMAGING RECORDERHoneywell, Inc.K901385GABRIEL MEDICAL CLS THERMAL RECORDERGabriel Medical, 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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