FDA 510(k)

oCare Wrist Pulse Oximeter

Número K: K183556 · 2019-02-15

RequerenteTaiwan Biophotonic Corporation

Data da decisão2019-02-15

Código do produtoDQA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

oCare Wrist Pulse Oximeter is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Biophotonic Corporation. It received FDA 510(k) clearance on 2019-02-15 under 510(k) number K183556. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the oCare Wrist Pulse Oximeter?

oCare Wrist Pulse Oximeter is a medical device that received FDA 510(k) clearance on 2019-02-15. The listed applicant is Taiwan Biophotonic Corporation. The 510(k) number is K183556.

When did oCare Wrist Pulse Oximeter receive FDA 510(k) clearance?

oCare Wrist Pulse Oximeter received FDA 510(k) clearance on 2019-02-15, under 510(k) number K183556.

Who is the listed applicant for oCare Wrist Pulse Oximeter?

The FDA 510(k) record lists Taiwan Biophotonic Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for oCare Wrist Pulse Oximeter?

The FDA product code for oCare Wrist Pulse Oximeter is DQA.

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Dispositivos Relacionados (Código: DQA)

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