Burn Resuscitation Decision Support System - Clinical (BRDSS-C)— 510(k) K140387

Name: FDA 510(k) clearance K140387
Creator: U.S. Food and Drug Administration
Published: 2014-12-23

Substantially Equivalent

The Surgeon General, Department of the Army

FDA 510(k) clearance K140387 for Burn Resuscitation Decision Support System - Clinical (BRDSS-C), Substantially Equivalent on 2014-12-23. Applicant: The Surgeon General, Department of the Army. Device class: 2.

Clearance details

Applicant: The Surgeon General, Department of the Army
Product code: Code PDT
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 2014-02-14
Decision date: 2014-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Detrick, MD, US

Download summary PDF View on FDA.gov ↗

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