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FDA 510(k)

ECG100+, ECG200+

K-Number: K160840 · 2016-08-12

ApplicantCardioline S.P.A
Decision Date2016-08-12
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG100+, ECG200+ is a medical device manufactured by Cardioline S.P.A. It received FDA 510(k) clearance on 2016-08-12 under approval number K160840. 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 ECG100+, ECG200+?

ECG100+, ECG200+ is a medical device that received FDA 510(k) clearance on 2016-08-12. It is manufactured by Cardioline S.P.A. The 510(k) number is K160840.

When was ECG100+, ECG200+ approved by the FDA?

ECG100+, ECG200+ received FDA 510(k) clearance on 2016-08-12, under approval number K160840.

What company makes ECG100+, ECG200+?

ECG100+, ECG200+ is manufactured by Cardioline S.P.A.

What is the FDA product code for ECG100+, ECG200+?

The FDA product code for ECG100+, ECG200+ is DPS.

Other Devices by Cardioline S.P.A

K160746CARDIOLINE touchECG K220526HD+12, HD+15

Related Devices (Code: DPS)

K160746CARDIOLINE touchECGCardioline S.P.A K152135Quantitative Electrocardiographic Detector (QED 2000)Acme Portable Machines, Inc. K161302PC ECGEdan Instruments, Inc. K152863Portable ECG MonitorContec Medical Systems Co.,Ltd K152043Diagnostic Station DS20Schiller AG K151135MODEL 621/624 BIOMAGNETOMETERTristan Technologies, Inc.

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.

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