BIOSIGN STEAM-24 BIOLOGICAL INDICATOR— 510(k) K032723

Name: FDA 510(k) clearance K032723
Creator: U.S. Food and Drug Administration
Published: 2003-10-01

Substantially Equivalent

Getinge USA, Inc.

FDA 510(k) clearance K032723 for BIOSIGN STEAM-24 BIOLOGICAL INDICATOR, Substantially Equivalent on 2003-10-01. Applicant: Getinge USA, Inc.. Device class: 2.

Clearance details

Applicant: Getinge USA, Inc.
Product code: Code FRC
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2003-09-03
Decision date: 2003-10-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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