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FDA 510(k)

MODEL U-1000 ULTRASONIC SCANNER

K-Number: K851902 · 1985-09-27

ApplicantFukuda Denshi USA, Inc.
Decision Date1985-09-27
Product CodeHEM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODEL U-1000 ULTRASONIC SCANNER 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 1985-09-27 under 510(k) number K851902. The device is classified under product code HEM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL U-1000 ULTRASONIC SCANNER?

MODEL U-1000 ULTRASONIC SCANNER is a medical device that received FDA 510(k) clearance on 1985-09-27. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K851902.

When did MODEL U-1000 ULTRASONIC SCANNER receive FDA 510(k) clearance?

MODEL U-1000 ULTRASONIC SCANNER received FDA 510(k) clearance on 1985-09-27, under 510(k) number K851902.

Who is the listed applicant for MODEL U-1000 ULTRASONIC SCANNER?

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 MODEL U-1000 ULTRASONIC SCANNER?

The FDA product code for MODEL U-1000 ULTRASONIC SCANNER is HEM.

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Other records listing Fukuda Denshi USA, Inc. as applicant

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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: HEM)

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.

K951393ABACUS OB ULTRASOUNG COMPUTER SOFTWARESolomon Technology LabsK942490BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUNDMedical Soft, Inc.K910426SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENTShimadzu Medical SystemsK905000ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCERCorometrics Medical Systems, Inc.K900505SONOACE 88 PORTABLE ULTRASOUND SCANNERMedison Co., Ltd.K900271MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINKDigisonics, 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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