geko T-2 and geko T-3 Neuromuscular Stimulators
K-Number: K191113 · 2019-09-18
ApplicantFirstkind Limited
Decision Date2019-09-18
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
geko T-2 and geko T-3 Neuromuscular Stimulators is a medical device manufactured by Firstkind Limited. It received FDA 510(k) clearance on 2019-09-18 under approval number K191113. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the geko T-2 and geko T-3 Neuromuscular Stimulators?
geko T-2 and geko T-3 Neuromuscular Stimulators is a medical device that received FDA 510(k) clearance on 2019-09-18. It is manufactured by Firstkind Limited. The 510(k) number is K191113.
When was geko T-2 and geko T-3 Neuromuscular Stimulators approved by the FDA?
geko T-2 and geko T-3 Neuromuscular Stimulators received FDA 510(k) clearance on 2019-09-18, under approval number K191113.
What company makes geko T-2 and geko T-3 Neuromuscular Stimulators?
geko T-2 and geko T-3 Neuromuscular Stimulators is manufactured by Firstkind Limited.
What is the FDA product code for geko T-2 and geko T-3 Neuromuscular Stimulators?
The FDA product code for geko T-2 and geko T-3 Neuromuscular Stimulators is IPF.
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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.