FDA 510(k)

OE 1.5 SI

K-Number: K925858 · 1993-12-02

Decision Date1993-12-02

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

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 1993-12-02 under 510(k) number K925858. 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 OE 1.5 SI?

OE 1.5 SI is a medical device that received FDA 510(k) clearance on 1993-12-02. The listed applicant is Otsuka Electronics. The 510(k) number is K925858.

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

OE 1.5 SI received FDA 510(k) clearance on 1993-12-02, under 510(k) number K925858.

Who is the listed applicant for 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 OE 1.5 SI?

The FDA product code for 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.

K920543MRI OE 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.