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FDA 510(k)

PC ECG

K-Number: K160876 · 2017-02-15

ApplicantEdan Instruments, Inc.
Decision Date2017-02-15
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PC ECG is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2017-02-15 under 510(k) number K160876. 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 2017-02-15. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K160876.

When did PC ECG receive FDA 510(k) clearance?

PC ECG received FDA 510(k) clearance on 2017-02-15, under 510(k) number K160876.

Who is the listed applicant for PC ECG?

The FDA 510(k) record lists Edan Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PC ECG?

The FDA product code for PC ECG is DPS.

Other records listing Edan Instruments, Inc. 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.

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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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