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FDA 510(k)

PROFILE MULTI-PLATFORM SYSTEM

K-Number: K060033 · 2006-02-28

ApplicantSciton, Inc
Decision Date2006-02-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROFILE MULTI-PLATFORM SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sciton, Inc. It received FDA 510(k) clearance on 2006-02-28 under 510(k) number K060033. 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 PROFILE MULTI-PLATFORM SYSTEM?

PROFILE MULTI-PLATFORM SYSTEM is a medical device that received FDA 510(k) clearance on 2006-02-28. The listed applicant is Sciton, Inc. The 510(k) number is K060033.

When did PROFILE MULTI-PLATFORM SYSTEM receive FDA 510(k) clearance?

PROFILE MULTI-PLATFORM SYSTEM received FDA 510(k) clearance on 2006-02-28, under 510(k) number K060033.

Who is the listed applicant for PROFILE MULTI-PLATFORM SYSTEM?

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

What is the FDA product code for PROFILE MULTI-PLATFORM SYSTEM?

The FDA product code for PROFILE MULTI-PLATFORM SYSTEM 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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