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FDA 510(k)

Magma Spark Pro (Magma Spark Plus, Alpha)

K-Number: K183307 · 2018-12-11

ApplicantFormatk Systems , Ltd.
Decision Date2018-12-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Magma Spark Pro (Magma Spark Plus, Alpha) is the device name listed in this FDA 510(k) record. The listed applicant is Formatk Systems , Ltd.. It received FDA 510(k) clearance on 2018-12-11 under 510(k) number K183307. 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 Magma Spark Pro (Magma Spark Plus, Alpha)?

Magma Spark Pro (Magma Spark Plus, Alpha) is a medical device that received FDA 510(k) clearance on 2018-12-11. The listed applicant is Formatk Systems , Ltd.. The 510(k) number is K183307.

When did Magma Spark Pro (Magma Spark Plus, Alpha) receive FDA 510(k) clearance?

Magma Spark Pro (Magma Spark Plus, Alpha) received FDA 510(k) clearance on 2018-12-11, under 510(k) number K183307.

Who is the listed applicant for Magma Spark Pro (Magma Spark Plus, Alpha)?

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

What is the FDA product code for Magma Spark Pro (Magma Spark Plus, Alpha)?

The FDA product code for Magma Spark Pro (Magma Spark Plus, Alpha) is GEX. This falls under the Gastroenterology category.

Other records listing Formatk Systems , Ltd. as applicant

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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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