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FDA 510(k)

SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT

K-Number: K890913 · 1989-09-06

ApplicantShimadzu Precision Instruments, Inc.
Decision Date1989-09-06
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Precision Instruments, Inc.. It received FDA 510(k) clearance on 1989-09-06 under 510(k) number K890913. 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 SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT?

SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT is a medical device that received FDA 510(k) clearance on 1989-09-06. The listed applicant is Shimadzu Precision Instruments, Inc.. The 510(k) number is K890913.

When did SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT receive FDA 510(k) clearance?

SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT received FDA 510(k) clearance on 1989-09-06, under 510(k) number K890913.

Who is the listed applicant for SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT?

The FDA 510(k) record lists Shimadzu Precision Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT?

The FDA product code for SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT is IYO.

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Other records listing Shimadzu Precision Instruments, Inc. as applicant

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Related Devices (Code: IYO)

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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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