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FDA 510(k)

ULTRAWAVE III EX 1320

K-Number: K083207 · 2008-11-14

ApplicantQuanta System Spa
Decision Date2008-11-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ULTRAWAVE III EX 1320 is the device name listed in this FDA 510(k) record. The listed applicant is Quanta System Spa. It received FDA 510(k) clearance on 2008-11-14 under 510(k) number K083207. 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 ULTRAWAVE III EX 1320?

ULTRAWAVE III EX 1320 is a medical device that received FDA 510(k) clearance on 2008-11-14. The listed applicant is Quanta System Spa. The 510(k) number is K083207.

When did ULTRAWAVE III EX 1320 receive FDA 510(k) clearance?

ULTRAWAVE III EX 1320 received FDA 510(k) clearance on 2008-11-14, under 510(k) number K083207.

Who is the listed applicant for ULTRAWAVE III EX 1320?

The FDA 510(k) record lists Quanta System Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRAWAVE III EX 1320?

The FDA product code for ULTRAWAVE III EX 1320 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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