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FDA 510(k)

Electrocardiograph, model: ECG301

K-Number: K232816 · 2024-06-07

ApplicantShenzhen LE Medical Technology Co., Ltd.
Decision Date2024-06-07
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Electrocardiograph, model: ECG301 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen LE Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-06-07 under 510(k) number K232816. 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 Electrocardiograph, model: ECG301?

Electrocardiograph, model: ECG301 is a medical device that received FDA 510(k) clearance on 2024-06-07. The listed applicant is Shenzhen LE Medical Technology Co., Ltd.. The 510(k) number is K232816.

When did Electrocardiograph, model: ECG301 receive FDA 510(k) clearance?

Electrocardiograph, model: ECG301 received FDA 510(k) clearance on 2024-06-07, under 510(k) number K232816.

Who is the listed applicant for Electrocardiograph, model: ECG301?

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

What is the FDA product code for Electrocardiograph, model: ECG301?

The FDA product code for Electrocardiograph, model: ECG301 is DPS.

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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