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FDA 510(k)

EUB-165

K-Number: K895326 · 1990-03-22

ApplicantHitachi Medical Corp. of America
Decision Date1990-03-22
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EUB-165 is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Corp. of America. It received FDA 510(k) clearance on 1990-03-22 under 510(k) number K895326. The device is classified under product code DXK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUB-165?

EUB-165 is a medical device that received FDA 510(k) clearance on 1990-03-22. The listed applicant is Hitachi Medical Corp. of America. The 510(k) number is K895326.

When did EUB-165 receive FDA 510(k) clearance?

EUB-165 received FDA 510(k) clearance on 1990-03-22, under 510(k) number K895326.

Who is the listed applicant for EUB-165?

The FDA 510(k) record lists Hitachi Medical Corp. of America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EUB-165?

The FDA product code for EUB-165 is DXK.

Other records listing Hitachi Medical Corp. of America 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.

K994026EUB-6000 ULTRASOUND DIAGNOSTIC SCANNERK991535CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERASK991318CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERASK991129HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTALK981434EUP-OL334 LAPARASCOPICPROBEK954220EUB-8000

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Related Devices (Code: DXK)

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.

K181042Ultra ICE Plus – PI 9 MHz Peripheral Imaging CatheterBoston Scientific CorporationK160173Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)Boston Scientific CorporationK031148IN-VISION IMAGING SYSTEMJomed, Inc.K9348879750 ATHENA ETHERNET OPTIONS & W Medico Teknik A/SK913209ACCESSORY TO GENESIS III (GCFM)Biosound, Inc.K911384CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600Endosonics Corp.

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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