FDA 510(k)

Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)

Numéro K : K243049 · 2025-01-02

DemandeurHunan Accurate Bio-Medical Technology Co., Ltd.

Date de décision2025-01-02

Code produitDQA

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Accurate Bio-Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-01-02 under 510(k) number K243049. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)?

Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) is a medical device that received FDA 510(k) clearance on 2025-01-02. The listed applicant is Hunan Accurate Bio-Medical Technology Co., Ltd.. The 510(k) number is K243049.

When did Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) receive FDA 510(k) clearance?

Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) received FDA 510(k) clearance on 2025-01-02, under 510(k) number K243049.

Who is the listed applicant for Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)?

The FDA 510(k) record lists Hunan Accurate Bio-Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)?

The FDA product code for Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) is DQA.

Essais cliniques associés

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Autres dossiers indiquant Hunan Accurate Bio-Medical Technology Co., Ltd. en tant que demandeur

K252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)K252748Pelvic Floor Exerciser (PF01)K240808Pulse Oximeter (WS20A)K171241Pulse Oximeter

Dispositifs connexes (Code : DQA)

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbH K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin Systeme K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Oxymètre de Pouls (SP61)Avita Corporation K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Source officielle

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