NuEra Tight Family, EMS Model
K-Number: K201239 · 2020-12-31
ApplicantBios S.R.L.
Decision Date2020-12-31
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
NuEra Tight Family, EMS Model is a medical device manufactured by Bios S.R.L.. It received FDA 510(k) clearance on 2020-12-31 under approval number K201239. 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 NuEra Tight Family, EMS Model?
NuEra Tight Family, EMS Model is a medical device that received FDA 510(k) clearance on 2020-12-31. It is manufactured by Bios S.R.L.. The 510(k) number is K201239.
When was NuEra Tight Family, EMS Model approved by the FDA?
NuEra Tight Family, EMS Model received FDA 510(k) clearance on 2020-12-31, under approval number K201239.
What company makes NuEra Tight Family, EMS Model?
NuEra Tight Family, EMS Model is manufactured by Bios S.R.L..
What is the FDA product code for NuEra Tight Family, EMS Model?
The FDA product code for NuEra Tight Family, EMS Model 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.