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FDA 510(k)

AZ ULTRASONIC SYSTEM

K-Number: K042056 · 2004-09-30

ApplicantJ. Morita USA, Inc.
Decision Date2004-09-30
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AZ ULTRASONIC SYSTEM 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 2004-09-30 under 510(k) number K042056. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AZ ULTRASONIC SYSTEM?

AZ ULTRASONIC SYSTEM is a medical device that received FDA 510(k) clearance on 2004-09-30. The listed applicant is J. Morita USA, Inc.. The 510(k) number is K042056.

When did AZ ULTRASONIC SYSTEM receive FDA 510(k) clearance?

AZ ULTRASONIC SYSTEM received FDA 510(k) clearance on 2004-09-30, under 510(k) number K042056.

Who is the listed applicant for AZ ULTRASONIC SYSTEM?

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 AZ ULTRASONIC SYSTEM?

The FDA product code for AZ ULTRASONIC SYSTEM is ELC.

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Related Devices (Code: ELC)

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

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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