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FDA 510(k)

ROTARY MASTER

K-Number: K992648 · 2000-01-31

ApplicantJ. Morita USA, Inc.
Decision Date2000-01-31
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ROTARY MASTER 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 2000-01-31 under 510(k) number K992648. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROTARY MASTER?

ROTARY MASTER is a medical device that received FDA 510(k) clearance on 2000-01-31. The listed applicant is J. Morita USA, Inc.. The 510(k) number is K992648.

When did ROTARY MASTER receive FDA 510(k) clearance?

ROTARY MASTER received FDA 510(k) clearance on 2000-01-31, under 510(k) number K992648.

Who is the listed applicant for ROTARY MASTER?

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 ROTARY MASTER?

The FDA product code for ROTARY MASTER is EBW.

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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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