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FDA 510(k)

NuEra Tight Family, EMS Model

K-Number: K201239 · 2020-12-31

ApplicantBios S.R.L.
Decision Date2020-12-31
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

NuEra Tight Family, EMS Model 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 2020-12-31 under 510(k) number K201239. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NuEra Tight Family, EMS Model?

NuEra Tight Family, EMS Model is a medical device that received FDA 510(k) clearance on 2020-12-31. The listed applicant is Bios S.R.L.. The 510(k) number is K201239.

When did NuEra Tight Family, EMS Model receive FDA 510(k) clearance?

NuEra Tight Family, EMS Model received FDA 510(k) clearance on 2020-12-31, under 510(k) number K201239.

Who is the listed applicant for NuEra Tight Family, EMS Model?

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 Family, EMS Model?

The FDA product code for NuEra Tight Family, EMS Model is NGX.

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.

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Related Devices (Code: NGX)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.