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FDA 510(k)

EXCEL TRIPULSE MODEL3000

K-Number: K924729 · 1993-01-15

ApplicantExcel Tech. , Ltd.
Decision Date1993-01-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EXCEL TRIPULSE MODEL3000 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 1993-01-15 under 510(k) number K924729. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXCEL TRIPULSE MODEL3000?

EXCEL TRIPULSE MODEL3000 is a medical device that received FDA 510(k) clearance on 1993-01-15. The listed applicant is Excel Tech. , Ltd.. The 510(k) number is K924729.

When did EXCEL TRIPULSE MODEL3000 receive FDA 510(k) clearance?

EXCEL TRIPULSE MODEL3000 received FDA 510(k) clearance on 1993-01-15, under 510(k) number K924729.

Who is the listed applicant for EXCEL TRIPULSE MODEL3000?

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 EXCEL TRIPULSE MODEL3000?

The FDA product code for EXCEL TRIPULSE MODEL3000 is GEX. This falls under the Gastroenterology category.

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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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