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FDA 510(k)

SYNCHRO HP PLATFORM

K-Number: K082039 · 2009-03-20

ApplicantEl.En Electronic Engineering Spa
Decision Date2009-03-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SYNCHRO HP PLATFORM is the device name listed in this FDA 510(k) record. The listed applicant is El.En Electronic Engineering Spa. It received FDA 510(k) clearance on 2009-03-20 under 510(k) number K082039. 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 SYNCHRO HP PLATFORM?

SYNCHRO HP PLATFORM is a medical device that received FDA 510(k) clearance on 2009-03-20. The listed applicant is El.En Electronic Engineering Spa. The 510(k) number is K082039.

When did SYNCHRO HP PLATFORM receive FDA 510(k) clearance?

SYNCHRO HP PLATFORM received FDA 510(k) clearance on 2009-03-20, under 510(k) number K082039.

Who is the listed applicant for SYNCHRO HP PLATFORM?

The FDA 510(k) record lists El.En Electronic Engineering Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNCHRO HP PLATFORM?

The FDA product code for SYNCHRO HP PLATFORM 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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