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FDA 510(k)

MRH-1500

K-Number: K922846 · 1993-06-08

ApplicantHitachi Medical Systems America, Inc.
Decision Date1993-06-08
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MRH-1500 is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 1993-06-08 under 510(k) number K922846. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRH-1500?

MRH-1500 is a medical device that received FDA 510(k) clearance on 1993-06-08. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K922846.

When did MRH-1500 receive FDA 510(k) clearance?

MRH-1500 received FDA 510(k) clearance on 1993-06-08, under 510(k) number K922846.

Who is the listed applicant for MRH-1500?

The FDA 510(k) record lists Hitachi Medical Systems America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MRH-1500?

The FDA product code for MRH-1500 is LNH.

Other records listing Hitachi Medical Systems America, Inc. 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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