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FDA 510(k)

EASY ECG PC BASED ELECTROCARDIOGRAPH

K-Number: K972996 · 1998-04-28

ApplicantAtes Medical S.R.L.
Decision Date1998-04-28
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EASY ECG PC BASED ELECTROCARDIOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Ates Medical S.R.L.. It received FDA 510(k) clearance on 1998-04-28 under 510(k) number K972996. 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 EASY ECG PC BASED ELECTROCARDIOGRAPH?

EASY ECG PC BASED ELECTROCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 1998-04-28. The listed applicant is Ates Medical S.R.L.. The 510(k) number is K972996.

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

EASY ECG PC BASED ELECTROCARDIOGRAPH received FDA 510(k) clearance on 1998-04-28, under 510(k) number K972996.

Who is the listed applicant for EASY ECG PC BASED ELECTROCARDIOGRAPH?

The FDA 510(k) record lists Ates Medical S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EASY ECG PC BASED ELECTROCARDIOGRAPH?

The FDA product code for EASY ECG PC BASED ELECTROCARDIOGRAPH is DPS.

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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.

K254255S-Patch CardioAIWellysis Corp.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 Commercial

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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