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FDA 510(k)

VITAL SIGNS MONITOR

K-Number: K153135 · 2016-02-25

ApplicantGuangdong Biolight Meditech Co., Ltd.
Decision Date2016-02-25
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VITAL SIGNS MONITOR is a medical device manufactured by Guangdong Biolight Meditech Co., Ltd.. It received FDA 510(k) clearance on 2016-02-25 under approval number K153135. 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 2016-02-25. It is manufactured by Guangdong Biolight Meditech Co., Ltd.. The 510(k) number is K153135.

When was VITAL SIGNS MONITOR approved by the FDA?

VITAL SIGNS MONITOR received FDA 510(k) clearance on 2016-02-25, under approval number K153135.

What company makes VITAL SIGNS MONITOR?

VITAL SIGNS MONITOR is manufactured by Guangdong Biolight Meditech 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 Guangdong Biolight Meditech Co., Ltd.

K160349Electronic Sphygmomanometer K153580Central Monitoring System K152739Electronic Thermometer K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D K170514Central Monitoring System K162234Truscope Ultra Patient Monitor

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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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