sensiFirm
K-Number: K170637 · 2017-07-14
ApplicantEl Global Trade, Ltd.
Decision Date2017-07-14
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
sensiFirm is a medical device manufactured by El Global Trade, Ltd.. It received FDA 510(k) clearance on 2017-07-14 under approval number K170637. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the sensiFirm?
sensiFirm is a medical device that received FDA 510(k) clearance on 2017-07-14. It is manufactured by El Global Trade, Ltd.. The 510(k) number is K170637.
When was sensiFirm approved by the FDA?
sensiFirm received FDA 510(k) clearance on 2017-07-14, under approval number K170637.
What company makes sensiFirm?
sensiFirm is manufactured by El Global Trade, Ltd..
What is the FDA product code for sensiFirm?
The FDA product code for sensiFirm is PBX.
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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.