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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Bios S.R.L.. It received FDA 510(k) clearance on 2021-04-21 under 510(k) 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. The listed applicant is Bios S.R.L.. The 510(k) number is K210867.

When did NuEra Tight RF, NuEra Tight RF Plus receive FDA 510(k) clearance?

NuEra Tight RF, NuEra Tight RF Plus received FDA 510(k) clearance on 2021-04-21, under 510(k) number K210867.

Who is the listed applicant for NuEra Tight RF, NuEra Tight RF Plus?

The FDA 510(k) record lists Bios S.R.L. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Bios S.R.L. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 10 devices →

Related Devices (Code: PBX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.