DEFIBRILLATOR ANALYZER - DA-2006P— 510(k) K110192

Name: FDA 510(k) clearance K110192
Creator: U.S. Food and Drug Administration
Published: 2011-02-08

Substantially Equivalent

Bc Group International, Inc.

FDA 510(k) clearance K110192 for DEFIBRILLATOR ANALYZER - DA-2006P, Substantially Equivalent on 2011-02-08. Applicant: Bc Group International, Inc.. Device class: 2.

Clearance details

Applicant: Bc Group International, Inc.
Product code: Code DRL
Device class: Class 2
Regulation: 21 CFR 870.5325
Advisory panel: Cardiovascular
Date received: 2011-01-24
Decision date: 2011-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oak Grove, MN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K110192

K-number listed on FDA's recall record

Z-0457-2016 — DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.Class III·Terminated·BC Group International Inc·20151028

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110192.

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