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FDA 510(k)

SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A

K-Number: K090936 · 2009-08-25

ApplicantContec Medical System Co., Ltd.
Decision Date2009-08-25
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A is the device name listed in this FDA 510(k) record. The listed applicant is Contec Medical System Co., Ltd.. It received FDA 510(k) clearance on 2009-08-25 under 510(k) number K090936. 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 SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A?

SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A is a medical device that received FDA 510(k) clearance on 2009-08-25. The listed applicant is Contec Medical System Co., Ltd.. The 510(k) number is K090936.

When did SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A receive FDA 510(k) clearance?

SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A received FDA 510(k) clearance on 2009-08-25, under 510(k) number K090936.

Who is the listed applicant for SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A?

The FDA 510(k) record lists Contec Medical System Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A?

The FDA product code for SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A is DPS.

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Other records listing Contec Medical System Co., Ltd. as applicant

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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

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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