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FDA 510(k)

EUB-555

K-Number: K926209 · 1994-06-03

ApplicantHitachi Medical Corp.
Decision Date1994-06-03
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EUB-555 is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Corp.. It received FDA 510(k) clearance on 1994-06-03 under 510(k) number K926209. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUB-555?

EUB-555 is a medical device that received FDA 510(k) clearance on 1994-06-03. The listed applicant is Hitachi Medical Corp.. The 510(k) number is K926209.

When did EUB-555 receive FDA 510(k) clearance?

EUB-555 received FDA 510(k) clearance on 1994-06-03, under 510(k) number K926209.

Who is the listed applicant for EUB-555?

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

What is the FDA product code for EUB-555?

The FDA product code for EUB-555 is IYO.

Other records listing Hitachi Medical Corp. 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.

K073310OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COILK061608MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNERK053258EUB-6500 DIAGNOSTIC ULTRASOUND SCANNERK042501ETG-4000 OPTICAL TOPOGRAPHY SYSTEMK013722MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNERK013723MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER

View all 11 devices →

Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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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