FDA 510(k)

EUB-8000

K-Number: K954220 · 1997-05-07

ApplicantHitachi Medical Corp. of America

Decision Date1997-05-07

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

EUB-8000 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 1997-05-07 under 510(k) number K954220. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUB-8000?

EUB-8000 is a medical device that received FDA 510(k) clearance on 1997-05-07. The listed applicant is Hitachi Medical Corp. of America. The 510(k) number is K954220.

When did EUB-8000 receive FDA 510(k) clearance?

EUB-8000 received FDA 510(k) clearance on 1997-05-07, under 510(k) number K954220.

Who is the listed applicant for EUB-8000?

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-8000?

The FDA product code for EUB-8000 is IYN.

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 SCANNER K991535CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS K991318CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS K991129HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL K981434EUP-OL334 LAPARASCOPICPROBE K962308EUB-905

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Related Devices (Code: IYN)

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.