FDA 510(k)

TrueCare Biomedix Tamper Evident Cap

Número K: K210818 · 2021-09-15

RequerenteUs Infusion Inc. D/B/A Truecare Biomedix-USA

Data da decisão2021-09-15

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

TrueCare Biomedix Tamper Evident Cap is the device name listed in this FDA 510(k) record. The listed applicant is Us Infusion Inc. D/B/A Truecare Biomedix-USA. It received FDA 510(k) clearance on 2021-09-15 under 510(k) number K210818. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TrueCare Biomedix Tamper Evident Cap?

TrueCare Biomedix Tamper Evident Cap is a medical device that received FDA 510(k) clearance on 2021-09-15. The listed applicant is Us Infusion Inc. D/B/A Truecare Biomedix-USA. The 510(k) number is K210818.

When did TrueCare Biomedix Tamper Evident Cap receive FDA 510(k) clearance?

TrueCare Biomedix Tamper Evident Cap received FDA 510(k) clearance on 2021-09-15, under 510(k) number K210818.

Who is the listed applicant for TrueCare Biomedix Tamper Evident Cap?

The FDA 510(k) record lists Us Infusion Inc. D/B/A Truecare Biomedix-USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TrueCare Biomedix Tamper Evident Cap?

The FDA product code for TrueCare Biomedix Tamper Evident Cap is FMF.

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