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FDA 510(k)

SDU-500 DIAGNOSTIC ULTRASOUND INSTRUMENT

K-Number: K875187 · 1988-12-12

ApplicantShimadzu Corp.
Decision Date1988-12-12
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SDU-500 DIAGNOSTIC ULTRASOUND INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Corp.. It received FDA 510(k) clearance on 1988-12-12 under 510(k) number K875187. 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-500 DIAGNOSTIC ULTRASOUND INSTRUMENT?

SDU-500 DIAGNOSTIC ULTRASOUND INSTRUMENT is a medical device that received FDA 510(k) clearance on 1988-12-12. The listed applicant is Shimadzu Corp.. The 510(k) number is K875187.

When did SDU-500 DIAGNOSTIC ULTRASOUND INSTRUMENT receive FDA 510(k) clearance?

SDU-500 DIAGNOSTIC ULTRASOUND INSTRUMENT received FDA 510(k) clearance on 1988-12-12, under 510(k) number K875187.

Who is the listed applicant for SDU-500 DIAGNOSTIC ULTRASOUND INSTRUMENT?

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

What is the FDA product code for SDU-500 DIAGNOSTIC ULTRASOUND INSTRUMENT?

The FDA product code for SDU-500 DIAGNOSTIC ULTRASOUND INSTRUMENT is IYO.

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Other records listing Shimadzu Corp. as applicant

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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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