FDA 510(k)

SPECTRADIGITAL SERIES V250DSP

K-Number: K954129 · 1995-12-22

ApplicantHitachi Medical Corp. of America

Decision Date1995-12-22

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SPECTRADIGITAL SERIES V250DSP 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 1995-12-22 under 510(k) number K954129. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRADIGITAL SERIES V250DSP?

SPECTRADIGITAL SERIES V250DSP is a medical device that received FDA 510(k) clearance on 1995-12-22. The listed applicant is Hitachi Medical Corp. of America. The 510(k) number is K954129.

When did SPECTRADIGITAL SERIES V250DSP receive FDA 510(k) clearance?

SPECTRADIGITAL SERIES V250DSP received FDA 510(k) clearance on 1995-12-22, under 510(k) number K954129.

Who is the listed applicant for SPECTRADIGITAL SERIES V250DSP?

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 SPECTRADIGITAL SERIES V250DSP?

The FDA product code for SPECTRADIGITAL SERIES V250DSP is KPS.

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Other records listing Hitachi Medical Corp. of America 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.