BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR

Automated External Defibrillators (non-wearable)

BIO-DETEK, INC.

The following data is part of a premarket notification filed by Bio-detek, Inc. with the FDA for Bio-detek Modified Adult Multi-function Electrode With Connector.

Pre-market Notification Details

Device IDK033771
510k NumberK033771
Device Name:BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR
ClassificationAutomated External Defibrillators (non-wearable)
Applicant BIO-DETEK, INC. 525 NARRAGANSETT PARK DR. Pawtucket,  RI  02861 -4323
ContactRobert Morse
CorrespondentRobert Morse
BIO-DETEK, INC. 525 NARRAGANSETT PARK DR. Pawtucket,  RI  02861 -4323
Product CodeMKJ  
CFR Regulation Number870.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-12-03
Decision Date2004-02-27
Summary:summary

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