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FDA 510(k)

UNISIGHT SYSTEM WITH UNIGATE

K-Number: K023394 · 2003-01-07

ApplicantElectronic Business Machine Co., Ltd. (Ebm)
Decision Date2003-01-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UNISIGHT SYSTEM WITH UNIGATE is the device name listed in this FDA 510(k) record. The listed applicant is Electronic Business Machine Co., Ltd. (Ebm). It received FDA 510(k) clearance on 2003-01-07 under 510(k) number K023394. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNISIGHT SYSTEM WITH UNIGATE?

UNISIGHT SYSTEM WITH UNIGATE is a medical device that received FDA 510(k) clearance on 2003-01-07. The listed applicant is Electronic Business Machine Co., Ltd. (Ebm). The 510(k) number is K023394.

When did UNISIGHT SYSTEM WITH UNIGATE receive FDA 510(k) clearance?

UNISIGHT SYSTEM WITH UNIGATE received FDA 510(k) clearance on 2003-01-07, under 510(k) number K023394.

Who is the listed applicant for UNISIGHT SYSTEM WITH UNIGATE?

The FDA 510(k) record lists Electronic Business Machine Co., Ltd. (Ebm) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNISIGHT SYSTEM WITH UNIGATE?

The FDA product code for UNISIGHT SYSTEM WITH UNIGATE is LLZ.

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Other records listing Electronic Business Machine Co., Ltd. (Ebm) 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.

K071166UNIWEB, VERSION 5.0K062743UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.0

Related Devices (Code: LLZ)

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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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