FDA 510(k)

Phoenix Digital Thermometer

N.º K: K201032 · 2021-10-29

SolicitantePhoenix Innovative Healthcare Manufacturers Pvt. , Ltd.

Fecha de decisión2021-10-29

Código de productoFLL

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Phoenix Digital Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.. It received FDA 510(k) clearance on 2021-10-29 under 510(k) number K201032. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Phoenix Digital Thermometer?

Phoenix Digital Thermometer is a medical device that received FDA 510(k) clearance on 2021-10-29. The listed applicant is Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.. The 510(k) number is K201032.

When did Phoenix Digital Thermometer receive FDA 510(k) clearance?

Phoenix Digital Thermometer received FDA 510(k) clearance on 2021-10-29, under 510(k) number K201032.

Who is the listed applicant for Phoenix Digital Thermometer?

The FDA 510(k) record lists Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Phoenix Digital Thermometer?

The FDA product code for Phoenix Digital Thermometer is FLL.

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Otros registros que enlistan a Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. como solicitante

K231123Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)

Dispositivos relacionados (Código: FLL)

K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)Unimed Medical Supplies, Inc.K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)Shenzhen Med-Link Electronics Tech Co., Ltd.K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd.K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)Shenzhen Medke Technology Co., Ltd.K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K243082Infrared ThermometerGuangzhou Daxin Health Technology Co., Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.