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FDA 510(k)

JOULE MULTI-PLATFORM SYSTEM

K-Number: K101916 · 2011-03-18

ApplicantSciton, Inc
Decision Date2011-03-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

JOULE 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 2011-03-18 under 510(k) number K101916. 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 JOULE MULTI-PLATFORM SYSTEM?

JOULE MULTI-PLATFORM SYSTEM is a medical device that received FDA 510(k) clearance on 2011-03-18. The listed applicant is Sciton, Inc. The 510(k) number is K101916.

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

JOULE MULTI-PLATFORM SYSTEM received FDA 510(k) clearance on 2011-03-18, under 510(k) number K101916.

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

The FDA product code for JOULE MULTI-PLATFORM SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Sciton, Inc as applicant

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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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