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FDA 510(k)

Vital Signs Monitor

K-Number: K211754 · 2021-11-15

ApplicantBeijing Choice Electronic Technology Co., Ltd.
Decision Date2021-11-15
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vital Signs Monitor is a medical device manufactured by Beijing Choice Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-15 under approval number K211754. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vital Signs Monitor?

Vital Signs Monitor is a medical device that received FDA 510(k) clearance on 2021-11-15. It is manufactured by Beijing Choice Electronic Technology Co., Ltd.. The 510(k) number is K211754.

When was Vital Signs Monitor approved by the FDA?

Vital Signs Monitor received FDA 510(k) clearance on 2021-11-15, under approval number K211754.

What company makes Vital Signs Monitor?

Vital Signs Monitor is manufactured by Beijing Choice Electronic Technology Co., Ltd..

What is the FDA product code for Vital Signs Monitor?

The FDA product code for Vital Signs Monitor is MWI.

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 40085833 The Measurement of Vital Signs in Pediatric Patients by Lifelight Software in Comparison to the Standard of Care: Protocol for the VISION-Junior Observational Study. JMIR research protocols (2025)

Other Devices by Beijing Choice Electronic Technology Co., Ltd.

K160268Fingertip Pulse Oximeter MD300CG11/MD300CG51 K161560Fingertip Pulse Oximeter MD300CN310 K152563Pulse Oximeter (MD300M/MD300K2) K162089Blood Pressure Monitor K181503Fingertip Pulse Oximeter K172366Wrist Pulse Oximeter

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Related Devices (Code: MWI)

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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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