MODEL 215M PATIENT SIMULATOR

Detector And Alarm, Arrhythmia

DYNATECH/NEVADA, INC.

The following data is part of a premarket notification filed by Dynatech/nevada, Inc. with the FDA for Model 215m Patient Simulator.

Pre-market Notification Details

Device IDK897074
510k NumberK897074
Device Name:MODEL 215M PATIENT SIMULATOR
ClassificationDetector And Alarm, Arrhythmia
Applicant DYNATECH/NEVADA, INC. 2000 ARROWHEAD DR. Carson City,  NV  89706 -0403
ContactD Hendricks
CorrespondentD Hendricks
DYNATECH/NEVADA, INC. 2000 ARROWHEAD DR. Carson City,  NV  89706 -0403
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-22
Decision Date1990-05-17

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