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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 a medical device manufactured by Surepulse Medical Limited. It received FDA 510(k) clearance on 2021-07-23 under approval 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. It is manufactured by Surepulse Medical Limited. The 510(k) number is K201887.

When was VS Newborn Heart Rate Monitor approved by the FDA?

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

What company makes VS Newborn Heart Rate Monitor?

VS Newborn Heart Rate Monitor is manufactured by Surepulse Medical Limited.

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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Official Source

View on FDA Database →

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

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