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FDA 510(k)

Sempulse Halo Vital Signs Monitor

K-Number: K232495 · 2024-05-16

ApplicantSempulse Corporation
Decision Date2024-05-16
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sempulse Halo Vital Signs Monitor is a medical device manufactured by Sempulse Corporation. It received FDA 510(k) clearance on 2024-05-16 under approval number K232495. 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 Sempulse Halo Vital Signs Monitor?

Sempulse Halo Vital Signs Monitor is a medical device that received FDA 510(k) clearance on 2024-05-16. It is manufactured by Sempulse Corporation. The 510(k) number is K232495.

When was Sempulse Halo Vital Signs Monitor approved by the FDA?

Sempulse Halo Vital Signs Monitor received FDA 510(k) clearance on 2024-05-16, under approval number K232495.

What company makes Sempulse Halo Vital Signs Monitor?

Sempulse Halo Vital Signs Monitor is manufactured by Sempulse Corporation.

What is the FDA product code for Sempulse Halo Vital Signs Monitor?

The FDA product code for Sempulse Halo Vital Signs Monitor is DQA.

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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)

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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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