K-number	K233096
Device name	PRESSUREALERT® Pressure Monitoring System
Applicant	Position Health, LLC
Product code	SBO
Device class	Class I
Decision date	Jun 21, 2024
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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PRESSUREALERT® Pressure Monitoring System

Everything you need for a 510(k) submission. Nothing you don't.