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FDA 510(k)

Boppli Infant Blood Pressure Monitor

K-Number: K223873 · 2023-09-29

ApplicantPyrames, Inc.
Decision Date2023-09-29
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Boppli Infant Blood Pressure Monitor is a medical device manufactured by Pyrames, Inc.. It received FDA 510(k) clearance on 2023-09-29 under approval number K223873. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Boppli Infant Blood Pressure Monitor?

Boppli Infant Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2023-09-29. It is manufactured by Pyrames, Inc.. The 510(k) number is K223873.

When was Boppli Infant Blood Pressure Monitor approved by the FDA?

Boppli Infant Blood Pressure Monitor received FDA 510(k) clearance on 2023-09-29, under approval number K223873.

What company makes Boppli Infant Blood Pressure Monitor?

Boppli Infant Blood Pressure Monitor is manufactured by Pyrames, Inc..

What is the FDA product code for Boppli Infant Blood Pressure Monitor?

The FDA product code for Boppli Infant Blood Pressure Monitor is DXN.

Related Clinical Trials

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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: 41623865 Case Report: Hypertensive encephalopathy presents with complex types of sleep breathing events. Frontiers in cardiovascular medicine (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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