Type 5 Integrating Indicator for Steam (CSPN-15)— 510(k) K242860

Name: FDA 510(k) clearance K242860
Creator: U.S. Food and Drug Administration
Published: 2025-01-17

Substantially Equivalent

True Indicating, LLC

FDA 510(k) clearance K242860 for Type 5 Integrating Indicator for Steam (CSPN-15), Substantially Equivalent on 2025-01-17. Applicant: True Indicating, LLC. Device class: 2.

Clearance details

Applicant: True Indicating, LLC
Product code: Product code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2024-09-20
Decision date: 2025-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toledo, OH, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.