QA-40M Defibrillator Tester

FDA 510(k) K963190 · Metron U.S., Inc.

Substantially Equivalent

510(k) numberK963190

Submission

Device name
QA-40M Defibrillator Tester
Applicant
Metron U.S., Inc.
Grand Rapids, MI, US
Received
August 15, 1996
Decision date
July 1, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DRL – Tester, Defibrillator
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5325
Specialty
Cardiovascular

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K190437Delta 3300DRL · Traditional Netech Corporation08/28/2019SE
K182905UniPulseDRL · Traditional Seaward Group12/14/2018SE
K153210Defibrillator Analyzer Variable LoadDRL · Traditional Bc Group International, Inc.12/21/2015SE
K110192Defibrillator Analyzer - DA-2006PDRL · Traditional Bc Group International, Inc.02/08/2011SE
K083347Impulse 7010 Defibrillator Selectable LoadsDRL · Traditional Fluke Biomedical12/24/2008SE
K072114Impulse 6000D/7000DPDRL · Traditional Fluke Biomedical01/28/2008SE
K062099Phase 3, Model DT-1DRL · Traditional Datrend Systems, Inc.01/25/2007SE
K030547Modification to Zap Guard Defibrillator Test ProbeDRL · Special Guardian Angel Products, Inc.07/11/2003SE
K961595Defibrillator Analyzer, Delta 1000DRL · Traditional Netech Corp.10/29/1996SE
K954391Models QED-6, 6M and 6H Defibrillator Analyzer with Optional Universal Pacemaker Load…DRL · Traditional Bio-Tek Instruments, Inc.11/17/1995SE

More from Bio-Tek Instruments, Inc.

510(k)DeviceDecision
K982020Metron Qa-Ids I.V. Pump TesterFRN · Traditional 09/30/1998SE
K973991Metron QA-510 SPO2 AnalyzerDQA · Traditional 01/16/1998SE
K963198PS-41 6M Patient SimulatorDPS · Traditional 03/05/1997SE

Questions and answers

When was QA-40M Defibrillator Tester cleared by the FDA?

QA-40M Defibrillator Tester (K963190) received a 510(k) decision of Substantially Equivalent on July 1, 1997, 320 days after the submission was received.

What is the product code of K963190?

The FDA product code is DRL – Tester, Defibrillator, a Class II (moderate risk) device regulated under 21 CFR 870.5325.