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FDA 510(k)

Endophys Blood Pressure Monitor model BPM-30

K-Number: K231586 · 2023-11-03

ApplicantEndophys Technologies, LLC
Decision Date2023-11-03
Product CodeDSK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Endophys Blood Pressure Monitor model BPM-30 is a medical device manufactured by Endophys Technologies, LLC. It received FDA 510(k) clearance on 2023-11-03 under approval number K231586. The device is classified under product code DSK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endophys Blood Pressure Monitor model BPM-30?

Endophys Blood Pressure Monitor model BPM-30 is a medical device that received FDA 510(k) clearance on 2023-11-03. It is manufactured by Endophys Technologies, LLC. The 510(k) number is K231586.

When was Endophys Blood Pressure Monitor model BPM-30 approved by the FDA?

Endophys Blood Pressure Monitor model BPM-30 received FDA 510(k) clearance on 2023-11-03, under approval number K231586.

What company makes Endophys Blood Pressure Monitor model BPM-30?

Endophys Blood Pressure Monitor model BPM-30 is manufactured by Endophys Technologies, LLC.

What is the FDA product code for Endophys Blood Pressure Monitor model BPM-30?

The FDA product code for Endophys Blood Pressure Monitor model BPM-30 is DSK.

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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: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026) PMID: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025)

Related Devices (Code: DSK)

K160945Endophys Blood Pressure MonitorEndophys Holdings, LLC

Official Source

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

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