FDA 510(k)

Pivot System Sterilization case

Número K: K181845 · 2019-11-25

Data da decisão2019-11-25

Código do produtoKCT

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pivot System Sterilization case is the device name listed in this FDA 510(k) record. The listed applicant is Rp Medical, Inc.. It received FDA 510(k) clearance on 2019-11-25 under 510(k) number K181845. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Pivot System Sterilization case?

Pivot System Sterilization case is a medical device that received FDA 510(k) clearance on 2019-11-25. The listed applicant is Rp Medical, Inc.. The 510(k) number is K181845.

When did Pivot System Sterilization case receive FDA 510(k) clearance?

Pivot System Sterilization case received FDA 510(k) clearance on 2019-11-25, under 510(k) number K181845.

Who is the listed applicant for Pivot System Sterilization case?

The FDA 510(k) record lists Rp Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pivot System Sterilization case?

The FDA product code for Pivot System Sterilization case is KCT.

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