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FDA 510(k)

SEVEN ADD'L TRANSDUCERS FOR THE EUB-450 ULTRASOUND

K-Number: K900683 · 1990-08-31

ApplicantHitachi Medical Corp. of America
Decision Date1990-08-31
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SEVEN ADD'L TRANSDUCERS FOR THE EUB-450 ULTRASOUND 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 1990-08-31 under 510(k) number K900683. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEVEN ADD'L TRANSDUCERS FOR THE EUB-450 ULTRASOUND?

SEVEN ADD'L TRANSDUCERS FOR THE EUB-450 ULTRASOUND is a medical device that received FDA 510(k) clearance on 1990-08-31. The listed applicant is Hitachi Medical Corp. of America. The 510(k) number is K900683.

When did SEVEN ADD'L TRANSDUCERS FOR THE EUB-450 ULTRASOUND receive FDA 510(k) clearance?

SEVEN ADD'L TRANSDUCERS FOR THE EUB-450 ULTRASOUND received FDA 510(k) clearance on 1990-08-31, under 510(k) number K900683.

Who is the listed applicant for SEVEN ADD'L TRANSDUCERS FOR THE EUB-450 ULTRASOUND?

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 SEVEN ADD'L TRANSDUCERS FOR THE EUB-450 ULTRASOUND?

The FDA product code for SEVEN ADD'L TRANSDUCERS FOR THE EUB-450 ULTRASOUND is ITX.

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Related Devices (Code: ITX)

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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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