FDA 510(k)

Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618

Número K: K212346 · 2022-05-05

RequerenteShenzhen Pango Medical Electronics Co., Ltd.

Data da decisão2022-05-05

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Pango Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2022-05-05 under 510(k) number K212346. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618?

Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618 is a medical device that received FDA 510(k) clearance on 2022-05-05. The listed applicant is Shenzhen Pango Medical Electronics Co., Ltd.. The 510(k) number is K212346.

When did Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618 receive FDA 510(k) clearance?

Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618 received FDA 510(k) clearance on 2022-05-05, under 510(k) number K212346.

Who is the listed applicant for Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618?

The FDA 510(k) record lists Shenzhen Pango Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618?

The FDA product code for Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618 is FLL.

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Outros registros que listam Shenzhen Pango Medical Electronics Co., Ltd. como candidato(a)

K240729Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61)K223291Electronic Blood Pressure Monitor

Dispositivos Relacionados (Código: FLL)

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Fonte oficial

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