Katalyst Mark 1 Muscle Stimulation System
K-Number: K171035 · 2017-09-06
ApplicantKatalyst, Inc.
Decision Date2017-09-06
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Katalyst Mark 1 Muscle Stimulation System is a medical device manufactured by Katalyst, Inc.. It received FDA 510(k) clearance on 2017-09-06 under approval number K171035. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Katalyst Mark 1 Muscle Stimulation System?
Katalyst Mark 1 Muscle Stimulation System is a medical device that received FDA 510(k) clearance on 2017-09-06. It is manufactured by Katalyst, Inc.. The 510(k) number is K171035.
When was Katalyst Mark 1 Muscle Stimulation System approved by the FDA?
Katalyst Mark 1 Muscle Stimulation System received FDA 510(k) clearance on 2017-09-06, under approval number K171035.
What company makes Katalyst Mark 1 Muscle Stimulation System?
Katalyst Mark 1 Muscle Stimulation System is manufactured by Katalyst, Inc..
What is the FDA product code for Katalyst Mark 1 Muscle Stimulation System?
The FDA product code for Katalyst Mark 1 Muscle Stimulation System is NGX.
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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.