NuEra Tight RF Model OptiStream
K-Number: K230755 · 2023-10-30
ApplicantBios S.R.L.
Decision Date2023-10-30
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
NuEra Tight RF Model OptiStream is a medical device manufactured by Bios S.R.L.. It received FDA 510(k) clearance on 2023-10-30 under approval number K230755. 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 Model OptiStream?
NuEra Tight RF Model OptiStream is a medical device that received FDA 510(k) clearance on 2023-10-30. It is manufactured by Bios S.R.L.. The 510(k) number is K230755.
When was NuEra Tight RF Model OptiStream approved by the FDA?
NuEra Tight RF Model OptiStream received FDA 510(k) clearance on 2023-10-30, under approval number K230755.
What company makes NuEra Tight RF Model OptiStream?
NuEra Tight RF Model OptiStream is manufactured by Bios S.R.L..
What is the FDA product code for NuEra Tight RF Model OptiStream?
The FDA product code for NuEra Tight RF Model OptiStream 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.