Delta 3300

Tester, Defibrillator

Netech Corporation

The following data is part of a premarket notification filed by Netech Corporation with the FDA for Delta 3300.

Pre-market Notification Details

Device IDK190437
510k NumberK190437
Device Name:Delta 3300
ClassificationTester, Defibrillator
Applicant Netech Corporation 110 Toledo Street Farmingdale,  NY  11735
ContactMohan Das
CorrespondentMukesh Kumar
Brij Strategic Consultations, LLC 20271 Goldenrod Lane, Suite 2020 Germantown,  MD  20876
Product CodeDRL  
CFR Regulation Number870.5325 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-22
Decision Date2019-08-28

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