FDA 510(k)

MRI OE 1.5 SI

K-Number: K920543 · 1992-07-10

Decision Date1992-07-10

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MRI OE 1.5 SI is the device name listed in this FDA 510(k) record. The listed applicant is Otsuka Electronics. It received FDA 510(k) clearance on 1992-07-10 under 510(k) number K920543. 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 MRI OE 1.5 SI?

MRI OE 1.5 SI is a medical device that received FDA 510(k) clearance on 1992-07-10. The listed applicant is Otsuka Electronics. The 510(k) number is K920543.

When did MRI OE 1.5 SI receive FDA 510(k) clearance?

MRI OE 1.5 SI received FDA 510(k) clearance on 1992-07-10, under 510(k) number K920543.

Who is the listed applicant for MRI OE 1.5 SI?

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

What is the FDA product code for MRI OE 1.5 SI?

The FDA product code for MRI OE 1.5 SI is LNH.

Other records listing Otsuka Electronics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K925858OE 1.5 SI

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.