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FDA 510(k)

CARDIOLINE touchECG

K-Number: K160746 · 2016-11-02

ApplicantCardioline S.P.A
Decision Date2016-11-02
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOLINE touchECG is a medical device manufactured by Cardioline S.P.A. It received FDA 510(k) clearance on 2016-11-02 under approval number K160746. 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 CARDIOLINE touchECG?

CARDIOLINE touchECG is a medical device that received FDA 510(k) clearance on 2016-11-02. It is manufactured by Cardioline S.P.A. The 510(k) number is K160746.

When was CARDIOLINE touchECG approved by the FDA?

CARDIOLINE touchECG received FDA 510(k) clearance on 2016-11-02, under approval number K160746.

What company makes CARDIOLINE touchECG?

CARDIOLINE touchECG is manufactured by Cardioline S.P.A.

What is the FDA product code for CARDIOLINE touchECG?

The FDA product code for CARDIOLINE touchECG is DPS.

Other Devices by Cardioline S.P.A

K160840ECG100+, ECG200+ K220526HD+12, HD+15

Related Devices (Code: DPS)

K160840ECG100+, ECG200+Cardioline 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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