BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS)— 510(k) K121659

Name: FDA 510(k) clearance K121659
Creator: U.S. Food and Drug Administration
Published: 2013-04-18

Substantially Equivalent

Arcos, Inc.

FDA 510(k) clearance K121659 for BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS), Substantially Equivalent on 2013-04-18. Applicant: Arcos, Inc.. Device class: 2.

Clearance details

Applicant: Arcos, Inc.
Product code: Code PDT
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 2012-06-05
Decision date: 2013-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PDT

view all

K140387 — Burn Resuscitation Decision Support System - Clinical (BRDSS-C)2014-12-23

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