MODEL ECG100 SIMULATOR

Electrocardiograph

DYNATECH/NEVADA, INC.

The following data is part of a premarket notification filed by Dynatech/nevada, Inc. with the FDA for Model Ecg100 Simulator.

Pre-market Notification Details

Device IDK897029
510k NumberK897029
Device Name:MODEL ECG100 SIMULATOR
ClassificationElectrocardiograph
Applicant DYNATECH/NEVADA, INC. 2000 ARROWHEAD DR. Carson City,  NV  89706 -0403
ContactThomas D Hendricks
CorrespondentThomas D Hendricks
DYNATECH/NEVADA, INC. 2000 ARROWHEAD DR. Carson City,  NV  89706 -0403
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-18
Decision Date1990-04-26

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