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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 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 2016-08-12 under 510(k) 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. The listed applicant is Cardioline S.P.A. The 510(k) number is K160840.

When did ECG100+, ECG200+ receive FDA 510(k) clearance?

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

Who is the listed applicant for ECG100+, ECG200+?

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 ECG100+, ECG200+?

The FDA product code for ECG100+, ECG200+ 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+15K160746CARDIOLINE touchECG

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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