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FDA 510(k)

DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010

K-Number: K101876 · 2011-03-01

ApplicantShenzhen Biocare Electronics Co., Ltd.
Decision Date2011-03-01
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010 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 2011-03-01 under 510(k) number K101876. 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 ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010?

DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010 is a medical device that received FDA 510(k) clearance on 2011-03-01. The listed applicant is Shenzhen Biocare Electronics Co., Ltd.. The 510(k) number is K101876.

When did DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010 receive FDA 510(k) clearance?

DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010 received FDA 510(k) clearance on 2011-03-01, under 510(k) number K101876.

Who is the listed applicant for DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010?

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 ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010?

The FDA product code for DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010 is DPS.

Related Clinical Trials

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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.

K123816DIGITAL ELECTROCARDIOGRAPHSK122712DIGITAL ELECTROCARDIOGRAPHK112431DIGITAL ELECTROCARDIOGRAPHK100626DOPPLER 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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