BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS

Electrocardiograph, Ambulatory (without Analysis)

BTL INDUSTRIES, INC

The following data is part of a premarket notification filed by Btl Industries, Inc with the FDA for Btl-08 Ecg Recorder Model Btl-08 Ecg Lc Plus, Btl-08 Ecg Lt Plus.

Pre-market Notification Details

Device IDK100310
510k NumberK100310
Device Name:BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS
ClassificationElectrocardiograph, Ambulatory (without Analysis)
Applicant BTL INDUSTRIES, INC 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin,  TX  78746
ContactRichard Vincins, Cqa, Rac (us,eu)
CorrespondentRichard Vincins, Cqa, Rac (us,eu)
BTL INDUSTRIES, INC 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin,  TX  78746
Product CodeMWJ  
CFR Regulation Number870.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-02-03
Decision Date2010-10-13

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