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FDA 510(k)

VS Newborn Heart Rate Monitor

K-Number: K201887 · 2021-07-23

ApplicantSurepulse Medical Limited
Decision Date2021-07-23
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VS Newborn Heart Rate Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Surepulse Medical Limited. It received FDA 510(k) clearance on 2021-07-23 under 510(k) number K201887. 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 VS Newborn Heart Rate Monitor?

VS Newborn Heart Rate Monitor is a medical device that received FDA 510(k) clearance on 2021-07-23. The listed applicant is Surepulse Medical Limited. The 510(k) number is K201887.

When did VS Newborn Heart Rate Monitor receive FDA 510(k) clearance?

VS Newborn Heart Rate Monitor received FDA 510(k) clearance on 2021-07-23, under 510(k) number K201887.

Who is the listed applicant for VS Newborn Heart Rate Monitor?

The FDA 510(k) record lists Surepulse Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VS Newborn Heart Rate Monitor?

The FDA product code for VS Newborn Heart Rate Monitor is DQA.

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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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