NuEra Tight, NuEra Tight EMS
K-Number: K200359 · 2020-08-11
ApplicantBios S.R.L.
Decision Date2020-08-11
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
NuEra Tight, NuEra Tight EMS is a medical device manufactured by Bios S.R.L.. It received FDA 510(k) clearance on 2020-08-11 under approval number K200359. 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, NuEra Tight EMS?
NuEra Tight, NuEra Tight EMS is a medical device that received FDA 510(k) clearance on 2020-08-11. It is manufactured by Bios S.R.L.. The 510(k) number is K200359.
When was NuEra Tight, NuEra Tight EMS approved by the FDA?
NuEra Tight, NuEra Tight EMS received FDA 510(k) clearance on 2020-08-11, under approval number K200359.
What company makes NuEra Tight, NuEra Tight EMS?
NuEra Tight, NuEra Tight EMS is manufactured by Bios S.R.L..
What is the FDA product code for NuEra Tight, NuEra Tight EMS?
The FDA product code for NuEra Tight, NuEra Tight EMS 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.