FDA 510(k)

SINGLE USE MANOMETER

Número K: K201666 · 2020-11-13

Data da decisão2020-11-13

Código do produtoCAP

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

SINGLE USE MANOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Flexicare Medical Limited.. It received FDA 510(k) clearance on 2020-11-13 under 510(k) number K201666. The device is classified under product code CAP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SINGLE USE MANOMETER?

SINGLE USE MANOMETER is a medical device that received FDA 510(k) clearance on 2020-11-13. The listed applicant is Flexicare Medical Limited.. The 510(k) number is K201666.

When did SINGLE USE MANOMETER receive FDA 510(k) clearance?

SINGLE USE MANOMETER received FDA 510(k) clearance on 2020-11-13, under 510(k) number K201666.

Who is the listed applicant for SINGLE USE MANOMETER?

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

What is the FDA product code for SINGLE USE MANOMETER?

The FDA product code for SINGLE USE MANOMETER is CAP.

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