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FDA 510(k)

PRESSUREALERT® Pressure Monitoring System

Número K: K233096 · 2024-06-21

RequerentePosition Health, LLC
Data da decisão2024-06-21
Código do produtoSBO
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Position Health, LLC. The 510(k) number is K233096.

When did PRESSUREALERT® Pressure Monitoring System receive FDA 510(k) clearance?

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

Who is the listed applicant for PRESSUREALERT® Pressure Monitoring System?

The FDA 510(k) record lists Position Health, LLC as the applicant. This does not by itself establish the device manufacturer.

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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