K-number	K210867
Device name	NuEra Tight RF, NuEra Tight RF Plus
Applicant	Bios S.R.L.
Product code	PBX
Device class	Class II
Decision date	Apr 21, 2021
Decision	Substantially Equivalent
Regulation	878.4400

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Source

View the full FDA submission: accessdata.fda.gov

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NuEra Tight RF, NuEra Tight RF Plus

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