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

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

Recalls naming K121659

K-number listed on FDA's recall record

Z-2295-2019 — Brand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 Catalog 1125, Burn Navigator¿ H2 Transport Package Burn Navigator User Manual Manual-1120 Burn Navigator User's Manual, Rev. F Battery: Panasonic Model CF-H2 Part Number CMP-1523Class II·Terminated·Arcos, Inc·20150316

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121659.

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