Digital Electrocardiograph
K-Number: K160092 · 2016-02-12
Decision Date2016-02-12
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Digital Electrocardiograph is a medical device manufactured by Shenzhen Biocare Bio-Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2016-02-12 under approval number K160092. 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 Digital Electrocardiograph?
Digital Electrocardiograph is a medical device that received FDA 510(k) clearance on 2016-02-12. It is manufactured by Shenzhen Biocare Bio-Medical Equipment Co., Ltd.. The 510(k) number is K160092.
When was Digital Electrocardiograph approved by the FDA?
Digital Electrocardiograph received FDA 510(k) clearance on 2016-02-12, under approval number K160092.
What company makes Digital Electrocardiograph?
Digital Electrocardiograph is manufactured by Shenzhen Biocare Bio-Medical Equipment Co., Ltd..
What is the FDA product code for Digital Electrocardiograph?
The FDA product code for Digital Electrocardiograph is DPS.
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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.