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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 the device name listed in this FDA 510(k) record. The listed applicant is Cardioline S.P.A. It received FDA 510(k) clearance on 2016-11-02 under 510(k) 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. The listed applicant is Cardioline S.P.A. The 510(k) number is K160746.

When did CARDIOLINE touchECG receive FDA 510(k) clearance?

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

Who is the listed applicant for CARDIOLINE touchECG?

The FDA 510(k) record lists Cardioline S.P.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOLINE touchECG?

The FDA product code for CARDIOLINE touchECG is DPS.

Other records listing Cardioline S.P.A as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: DPS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France CommercialK243252ZBPro DiagnosticZbeats, 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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