PHASE 3, MODEL DT-1

Tester, Defibrillator

DATREND SYSTEMS, INC.

The following data is part of a premarket notification filed by Datrend Systems, Inc. with the FDA for Phase 3, Model Dt-1.

Pre-market Notification Details

Device IDK062099
510k NumberK062099
Device Name:PHASE 3, MODEL DT-1
ClassificationTester, Defibrillator
Applicant DATREND SYSTEMS, INC. 3531 JACOMBS RD., UNIT 1 Richmond, British Columbia,  CA V6v 1z8
ContactRon Evans
CorrespondentRon Evans
DATREND SYSTEMS, INC. 3531 JACOMBS RD., UNIT 1 Richmond, British Columbia,  CA V6v 1z8
Product CodeDRL  
CFR Regulation Number870.5325 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-24
Decision Date2007-01-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B418PHASE380004400 K062099 000

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