Modification to Zap Guard Defibrillator Test Probe

FDA 510(k) K030547 · Guardian Angel Products, Inc.

Substantially Equivalent

510(k) numberK030547

Submission

Device name
Modification to Zap Guard Defibrillator Test Probe
Applicant
Guardian Angel Products, Inc.
Huntingdon Valley, PA, US
Received
February 20, 2003
Decision date
July 11, 2003
Decision
Substantially Equivalent (SESE)
Type
Special 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
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
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
K923840Needle-GrabberGDF · Traditional 07/13/1993SE
K923835The Eleventh FingerGDF · Traditional 07/09/1993SE
K910687Guardian Gel, Surgeon's Gloving CreamKGQ · Traditional 10/11/1991SE
K896985Zap-GuardDRL · Traditional 07/31/1990SE

Questions and answers

When was Modification to Zap Guard Defibrillator Test Probe cleared by the FDA?

Modification to Zap Guard Defibrillator Test Probe (K030547) received a 510(k) decision of Substantially Equivalent on July 11, 2003, 141 days after the submission was received.

What is the product code of K030547?

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