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FDA 510(k)

PRESSUREALERT® Pressure Monitoring System

K-Number: K233096 · 2024-06-21

ApplicantPosition Health, LLC
Decision Date2024-06-21
Product CodeSBO
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRESSUREALERT® Pressure Monitoring System is a medical device manufactured by Position Health, LLC. It received FDA 510(k) clearance on 2024-06-21 under approval number K233096. The device is classified under product code SBO. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESSUREALERT® Pressure Monitoring System?

PRESSUREALERT® Pressure Monitoring System is a medical device that received FDA 510(k) clearance on 2024-06-21. It is manufactured by Position Health, LLC. The 510(k) number is K233096.

When was PRESSUREALERT® Pressure Monitoring System approved by the FDA?

PRESSUREALERT® Pressure Monitoring System received FDA 510(k) clearance on 2024-06-21, under approval number K233096.

What company makes PRESSUREALERT® Pressure Monitoring System?

PRESSUREALERT® Pressure Monitoring System is manufactured by Position Health, LLC.

What is the FDA product code for PRESSUREALERT® Pressure Monitoring System?

The FDA product code for PRESSUREALERT® Pressure Monitoring System is SBO.

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026) PMID: 41491965 From stones to system: integrating kidney stones disease into the cardiovascular-kidney-metabolic continuum. Current opinion in nephrology and hypertension (2026)

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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