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FDA 510(k)

EMU128S, MODEL EX-NW-128S

K-Number: K040360 · 2004-03-12

ApplicantExcel Tech. , Ltd.
Decision Date2004-03-12
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EMU128S, MODEL EX-NW-128S is the device name listed in this FDA 510(k) record. The listed applicant is Excel Tech. , Ltd.. It received FDA 510(k) clearance on 2004-03-12 under 510(k) number K040360. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMU128S, MODEL EX-NW-128S?

EMU128S, MODEL EX-NW-128S is a medical device that received FDA 510(k) clearance on 2004-03-12. The listed applicant is Excel Tech. , Ltd.. The 510(k) number is K040360.

When did EMU128S, MODEL EX-NW-128S receive FDA 510(k) clearance?

EMU128S, MODEL EX-NW-128S received FDA 510(k) clearance on 2004-03-12, under 510(k) number K040360.

Who is the listed applicant for EMU128S, MODEL EX-NW-128S?

The FDA 510(k) record lists Excel Tech. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMU128S, MODEL EX-NW-128S?

The FDA product code for EMU128S, MODEL EX-NW-128S is GWQ.

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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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