PC ECG
K-Number: K160876 · 2017-02-15
ApplicantEdan Instruments, Inc.
Decision Date2017-02-15
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
PC ECG is a medical device manufactured by Edan Instruments, Inc.. It received FDA 510(k) clearance on 2017-02-15 under approval number K160876. 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 PC ECG?
PC ECG is a medical device that received FDA 510(k) clearance on 2017-02-15. It is manufactured by Edan Instruments, Inc.. The 510(k) number is K160876.
When was PC ECG approved by the FDA?
PC ECG received FDA 510(k) clearance on 2017-02-15, under approval number K160876.
What company makes PC ECG?
PC ECG is manufactured by Edan Instruments, Inc..
What is the FDA product code for PC ECG?
The FDA product code for PC ECG 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.