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FDA 510(k)

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 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 2023-05-02 under 510(k) 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. The listed applicant is Bios S.R.L.. The 510(k) number is K223907.

When did NuEra Tight RF Model APMD145.M70-US receive FDA 510(k) clearance?

NuEra Tight RF Model APMD145.M70-US received FDA 510(k) clearance on 2023-05-02, under 510(k) number K223907.

Who is the listed applicant for NuEra Tight RF Model APMD145.M70-US?

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 Model APMD145.M70-US?

The FDA product code for NuEra Tight RF Model APMD145.M70-US 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.