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FDA 510(k)

HANDHELD ECG MONITOR, MODEL MD100

K-Number: K080933 · 2008-09-26

ApplicantBeijing Choice Electronic Technololgy Co., Ltd.
Decision Date2008-09-26
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HANDHELD ECG MONITOR, MODEL MD100 is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Choice Electronic Technololgy Co., Ltd.. It received FDA 510(k) clearance on 2008-09-26 under 510(k) number K080933. 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 HANDHELD ECG MONITOR, MODEL MD100?

HANDHELD ECG MONITOR, MODEL MD100 is a medical device that received FDA 510(k) clearance on 2008-09-26. The listed applicant is Beijing Choice Electronic Technololgy Co., Ltd.. The 510(k) number is K080933.

When did HANDHELD ECG MONITOR, MODEL MD100 receive FDA 510(k) clearance?

HANDHELD ECG MONITOR, MODEL MD100 received FDA 510(k) clearance on 2008-09-26, under 510(k) number K080933.

Who is the listed applicant for HANDHELD ECG MONITOR, MODEL MD100?

The FDA 510(k) record lists Beijing Choice Electronic Technololgy Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HANDHELD ECG MONITOR, MODEL MD100?

The FDA product code for HANDHELD ECG MONITOR, MODEL MD100 is DPS.

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Other records listing Beijing Choice Electronic Technololgy 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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