FDA 510(k)

ROOT ZX

K-Number: K921979 · 1993-05-27

Decision Date1993-05-27

Product CodeLQY

DecisionSubstantially Equivalent

Device Summary

ROOT ZX is the device name listed in this FDA 510(k) record. The listed applicant is J. Morita USA, Inc.. It received FDA 510(k) clearance on 1993-05-27 under 510(k) number K921979. The device is classified under product code LQY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROOT ZX?

ROOT ZX is a medical device that received FDA 510(k) clearance on 1993-05-27. The listed applicant is J. Morita USA, Inc.. The 510(k) number is K921979.

When did ROOT ZX receive FDA 510(k) clearance?

ROOT ZX received FDA 510(k) clearance on 1993-05-27, under 510(k) number K921979.

Who is the listed applicant for ROOT ZX?

The FDA 510(k) record lists J. Morita USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROOT ZX?

The FDA product code for ROOT ZX is LQY.

Other records listing J. Morita USA, Inc. 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.

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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.