PRESSUREALERT® Pressure Monitoring System— 510(k) K233096

Name: FDA 510(k) clearance K233096
Creator: U.S. Food and Drug Administration
Published: 2024-06-21

Substantially Equivalent

Position Health, LLC

FDA 510(k) clearance K233096 for PRESSUREALERT® Pressure Monitoring System, Substantially Equivalent on 2024-06-21. Applicant: Position Health, LLC. Device class: 1.

Clearance details

Applicant: Position Health, LLC
Product code: Code SBO
Device class: Class 1
Regulation: 21 CFR 880.2400
Advisory panel: General Hospital
Date received: 2023-09-26
Decision date: 2024-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, IL, US

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