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FDA 510(k)

Pulse Oximeter (WS20A)

K-Number: K240808 · 2024-10-03

ApplicantHunan Accurate Bio-Medical Technology Co., Ltd.
Decision Date2024-10-03
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pulse Oximeter (WS20A) 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 2024-10-03 under 510(k) number K240808. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pulse Oximeter (WS20A)?

Pulse Oximeter (WS20A) is a medical device that received FDA 510(k) clearance on 2024-10-03. The listed applicant is Hunan Accurate Bio-Medical Technology Co., Ltd.. The 510(k) number is K240808.

When did Pulse Oximeter (WS20A) receive FDA 510(k) clearance?

Pulse Oximeter (WS20A) received FDA 510(k) clearance on 2024-10-03, under 510(k) number K240808.

Who is the listed applicant for Pulse Oximeter (WS20A)?

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 (WS20A)?

The FDA product code for Pulse Oximeter (WS20A) is DQA.

Other records listing Hunan Accurate Bio-Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)K252748Pelvic Floor Exerciser (PF01)K243049Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)K171241Pulse Oximeter

Related Devices (Code: DQA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse 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 SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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