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FDA 510(k)

ELECTRONIC ULTRASOUND SCAN MODELS EUP-U12/012T/TC3

K-Number: K912363 · 1991-08-27

ApplicantHitachi Medical Corp. of America
Decision Date1991-08-27
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ELECTRONIC ULTRASOUND SCAN MODELS EUP-U12/012T/TC3 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 1991-08-27 under 510(k) number K912363. 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 ELECTRONIC ULTRASOUND SCAN MODELS EUP-U12/012T/TC3?

ELECTRONIC ULTRASOUND SCAN MODELS EUP-U12/012T/TC3 is a medical device that received FDA 510(k) clearance on 1991-08-27. The listed applicant is Hitachi Medical Corp. of America. The 510(k) number is K912363.

When did ELECTRONIC ULTRASOUND SCAN MODELS EUP-U12/012T/TC3 receive FDA 510(k) clearance?

ELECTRONIC ULTRASOUND SCAN MODELS EUP-U12/012T/TC3 received FDA 510(k) clearance on 1991-08-27, under 510(k) number K912363.

Who is the listed applicant for ELECTRONIC ULTRASOUND SCAN MODELS EUP-U12/012T/TC3?

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 ELECTRONIC ULTRASOUND SCAN MODELS EUP-U12/012T/TC3?

The FDA product code for ELECTRONIC ULTRASOUND SCAN MODELS EUP-U12/012T/TC3 is ITX.

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Other records listing Hitachi Medical Corp. of America as applicant

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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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