NuEra Tight RF Model APMD145.M70-US
K-Number: K223907 · 2023-05-02
ApplicantBios S.R.L.
Decision Date2023-05-02
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
NuEra Tight RF Model APMD145.M70-US is a medical device manufactured by Bios S.R.L.. It received FDA 510(k) clearance on 2023-05-02 under approval number K223907. 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 APMD145.M70-US?
NuEra Tight RF Model APMD145.M70-US is a medical device that received FDA 510(k) clearance on 2023-05-02. It is manufactured by Bios S.R.L.. The 510(k) number is K223907.
When was NuEra Tight RF Model APMD145.M70-US approved by the FDA?
NuEra Tight RF Model APMD145.M70-US received FDA 510(k) clearance on 2023-05-02, under approval number K223907.
What company makes NuEra Tight RF Model APMD145.M70-US?
NuEra Tight RF Model APMD145.M70-US is manufactured by Bios S.R.L..
What is the FDA product code for NuEra Tight RF Model APMD145.M70-US?
The FDA product code for NuEra Tight RF Model APMD145.M70-US 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.