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FDA 510(k)

MULTIWAVE XR

K-Number: K051876 · 2005-09-09

ApplicantPacific Quantum Instruments, Inc.
Decision Date2005-09-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MULTIWAVE XR is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Quantum Instruments, Inc.. It received FDA 510(k) clearance on 2005-09-09 under 510(k) number K051876. 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 MULTIWAVE XR?

MULTIWAVE XR is a medical device that received FDA 510(k) clearance on 2005-09-09. The listed applicant is Pacific Quantum Instruments, Inc.. The 510(k) number is K051876.

When did MULTIWAVE XR receive FDA 510(k) clearance?

MULTIWAVE XR received FDA 510(k) clearance on 2005-09-09, under 510(k) number K051876.

Who is the listed applicant for MULTIWAVE XR?

The FDA 510(k) record lists Pacific Quantum Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTIWAVE XR?

The FDA product code for MULTIWAVE XR is GEX. This falls under the Gastroenterology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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