CONTEC Electrocardiograph
K-Number: K171360 · 2018-01-22
ApplicantContec Medical Systems Co.,Ltd
Decision Date2018-01-22
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
CONTEC Electrocardiograph is a medical device manufactured by Contec Medical Systems Co.,Ltd. It received FDA 510(k) clearance on 2018-01-22 under approval number K171360. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CONTEC Electrocardiograph?
CONTEC Electrocardiograph is a medical device that received FDA 510(k) clearance on 2018-01-22. It is manufactured by Contec Medical Systems Co.,Ltd. The 510(k) number is K171360.
When was CONTEC Electrocardiograph approved by the FDA?
CONTEC Electrocardiograph received FDA 510(k) clearance on 2018-01-22, under approval number K171360.
What company makes CONTEC Electrocardiograph?
CONTEC Electrocardiograph is manufactured by Contec Medical Systems Co.,Ltd.
What is the FDA product code for CONTEC Electrocardiograph?
The FDA product code for CONTEC Electrocardiograph is DPS.
Other Devices by Contec Medical Systems Co.,Ltd
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K202757CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor
K220245Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.