Getinge Assured MI Steam Migrating Integrator— 510(k) K242795

Name: FDA 510(k) clearance K242795
Creator: U.S. Food and Drug Administration
Published: 2024-10-15

Substantially Equivalent

Steritec Products Mfg. (A Getinge Group Company)

FDA 510(k) clearance K242795 for Getinge Assured MI Steam Migrating Integrator, Substantially Equivalent on 2024-10-15. Applicant: Steritec Products Mfg. (A Getinge Group Company). Device class: 2.

Clearance details

Applicant: Steritec Products Mfg. (A Getinge Group Company)
Product code: Product code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2024-09-16
Decision date: 2024-10-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Engelwood, CO, 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.