FDA 510(k)

Amazing+

Número K: K212586 · 2022-02-17

RequerenteAmazing Rubber Products Pvt, Ltd.

Data da decisão2022-02-17

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Amazing+ is the device name listed in this FDA 510(k) record. The listed applicant is Amazing Rubber Products Pvt, Ltd.. It received FDA 510(k) clearance on 2022-02-17 under 510(k) number K212586. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Amazing+?

Amazing+ is a medical device that received FDA 510(k) clearance on 2022-02-17. The listed applicant is Amazing Rubber Products Pvt, Ltd.. The 510(k) number is K212586.

When did Amazing+ receive FDA 510(k) clearance?

Amazing+ received FDA 510(k) clearance on 2022-02-17, under 510(k) number K212586.

Who is the listed applicant for Amazing+?

The FDA 510(k) record lists Amazing Rubber Products Pvt, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Amazing+?

The FDA product code for Amazing+ is LZA.

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Outros registros que listam Amazing Rubber Products Pvt, Ltd. como candidato(a)

K212584Blue Nitrile Examination Gloves Powder Free K212597Amazing+ Luvas de Exame de Latex Livre K212596Sterile Latex Surgical Gloves Powder Free

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