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FDA 510(k)

EUB-305 DIAGNOSTIC ULTRASOUND DEVICE

K-Number: K870878 · 1988-04-22

ApplicantHitachi Medical Corp. of America
Decision Date1988-04-22
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EUB-305 DIAGNOSTIC ULTRASOUND DEVICE 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 1988-04-22 under 510(k) number K870878. 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-305 DIAGNOSTIC ULTRASOUND DEVICE?

EUB-305 DIAGNOSTIC ULTRASOUND DEVICE is a medical device that received FDA 510(k) clearance on 1988-04-22. The listed applicant is Hitachi Medical Corp. of America. The 510(k) number is K870878.

When did EUB-305 DIAGNOSTIC ULTRASOUND DEVICE receive FDA 510(k) clearance?

EUB-305 DIAGNOSTIC ULTRASOUND DEVICE received FDA 510(k) clearance on 1988-04-22, under 510(k) number K870878.

Who is the listed applicant for EUB-305 DIAGNOSTIC ULTRASOUND DEVICE?

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-305 DIAGNOSTIC ULTRASOUND DEVICE?

The FDA product code for EUB-305 DIAGNOSTIC ULTRASOUND DEVICE is DXK.

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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

View all 32 devices →

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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