PC ECG
K-Number: K152427 · 2016-02-05
ApplicantEdan Instruments, Inc.
Decision Date2016-02-05
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 2016-02-05 under approval number K152427. 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 2016-02-05. It is manufactured by Edan Instruments, Inc.. The 510(k) number is K152427.
When was PC ECG approved by the FDA?
PC ECG received FDA 510(k) clearance on 2016-02-05, under approval number K152427.
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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K161302PC ECG
K161300Acclarix AX8 Diagnostic Ultrasound System
K152552Patient Monitor
K160790Acclarix LX8 Diagnostic Ultrasound System
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K152135Quantitative Electrocardiographic Detector (QED 2000)Acme Portable Machines, Inc.
K161302PC ECGEdan Instruments, Inc.
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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.