MEDSIM 300 PATIENT SIMULATOR

Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

DYNATECH/NEVADA, INC.

The following data is part of a premarket notification filed by Dynatech/nevada, Inc. with the FDA for Medsim 300 Patient Simulator.

Pre-market Notification Details

Device IDK935817
510k NumberK935817
Device Name:MEDSIM 300 PATIENT SIMULATOR
ClassificationMonitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Applicant DYNATECH/NEVADA, INC. 555 THIRTEENTH ST. N.W. Washington,  DC  20004 -1109
ContactHoward M Holstein
CorrespondentHoward M Holstein
DYNATECH/NEVADA, INC. 555 THIRTEENTH ST. N.W. Washington,  DC  20004 -1109
Product CodeDRT  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-12-02
Decision Date1994-01-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850540007164 K935817 000

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