Delta 3300

FDA 510(k) K190437 · Netech Corporation

Substantially Equivalent

510(k) numberK190437

Submission

Device name
Delta 3300
Applicant
Netech Corporation
Farmingdale, NY, US
Received
February 22, 2019
Decision date
August 28, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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

Other 510(k)s with product code DRL

510(k)DeviceApplicantDecision
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
K963190QA-40M Defibrillator TesterDRL · Traditional Metron U.S., Inc.07/01/1997SE
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
K961595Defibrillator Analyzer, Delta 1000DRL · Traditional 10/29/1996SE

Questions and answers

When was Delta 3300 cleared by the FDA?

Delta 3300 (K190437) received a 510(k) decision of Substantially Equivalent on August 28, 2019, 187 days after the submission was received.

What is the product code of K190437?

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