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FDA 510(k)

PROMETEY, MODEL G1-03

K-Number: K062071 · 2006-09-28

ApplicantSpectrum International
Decision Date2006-09-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROMETEY, MODEL G1-03 is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum International. It received FDA 510(k) clearance on 2006-09-28 under 510(k) number K062071. 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 PROMETEY, MODEL G1-03?

PROMETEY, MODEL G1-03 is a medical device that received FDA 510(k) clearance on 2006-09-28. The listed applicant is Spectrum International. The 510(k) number is K062071.

When did PROMETEY, MODEL G1-03 receive FDA 510(k) clearance?

PROMETEY, MODEL G1-03 received FDA 510(k) clearance on 2006-09-28, under 510(k) number K062071.

Who is the listed applicant for PROMETEY, MODEL G1-03?

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

What is the FDA product code for PROMETEY, MODEL G1-03?

The FDA product code for PROMETEY, MODEL G1-03 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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