NuEra Tight RF, NuEra Tight RF Plus
K-Number: K210867 · 2021-04-21
ApplicantBios S.R.L.
Decision Date2021-04-21
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
NuEra Tight RF, NuEra Tight RF Plus is a medical device manufactured by Bios S.R.L.. It received FDA 510(k) clearance on 2021-04-21 under approval number K210867. 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 NuEra Tight RF, NuEra Tight RF Plus?
NuEra Tight RF, NuEra Tight RF Plus is a medical device that received FDA 510(k) clearance on 2021-04-21. It is manufactured by Bios S.R.L.. The 510(k) number is K210867.
When was NuEra Tight RF, NuEra Tight RF Plus approved by the FDA?
NuEra Tight RF, NuEra Tight RF Plus received FDA 510(k) clearance on 2021-04-21, under approval number K210867.
What company makes NuEra Tight RF, NuEra Tight RF Plus?
NuEra Tight RF, NuEra Tight RF Plus is manufactured by Bios S.R.L..
What is the FDA product code for NuEra Tight RF, NuEra Tight RF Plus?
The FDA product code for NuEra Tight RF, NuEra Tight RF Plus 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.