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FDA 510(k)

DIGITAL ELECTROCARDIOGRAPHS

K-Number: K123816 · 2013-02-27

ApplicantShenzhen Biocare Electronics Co., Ltd.
Decision Date2013-02-27
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DIGITAL ELECTROCARDIOGRAPHS is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Biocare Electronics Co., Ltd.. It received FDA 510(k) clearance on 2013-02-27 under 510(k) number K123816. 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 DIGITAL ELECTROCARDIOGRAPHS?

DIGITAL ELECTROCARDIOGRAPHS is a medical device that received FDA 510(k) clearance on 2013-02-27. The listed applicant is Shenzhen Biocare Electronics Co., Ltd.. The 510(k) number is K123816.

When did DIGITAL ELECTROCARDIOGRAPHS receive FDA 510(k) clearance?

DIGITAL ELECTROCARDIOGRAPHS received FDA 510(k) clearance on 2013-02-27, under 510(k) number K123816.

Who is the listed applicant for DIGITAL ELECTROCARDIOGRAPHS?

The FDA 510(k) record lists Shenzhen Biocare Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGITAL ELECTROCARDIOGRAPHS?

The FDA product code for DIGITAL ELECTROCARDIOGRAPHS is DPS.

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Other records listing Shenzhen Biocare Electronics Co., Ltd. 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.

K122712DIGITAL ELECTROCARDIOGRAPHK112431DIGITAL ELECTROCARDIOGRAPHK101876DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010K100626DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200

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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