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FDA 510(k)

Digital Electrocardiograph

K-Number: K160092 · 2016-02-12

ApplicantShenzhen Biocare Bio-Medical Equipment Co., Ltd.
Decision Date2016-02-12
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Digital Electrocardiograph is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Biocare Bio-Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2016-02-12 under 510(k) number K160092. 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?

Digital Electrocardiograph is a medical device that received FDA 510(k) clearance on 2016-02-12. The listed applicant is Shenzhen Biocare Bio-Medical Equipment Co., Ltd.. The 510(k) number is K160092.

When did Digital Electrocardiograph receive FDA 510(k) clearance?

Digital Electrocardiograph received FDA 510(k) clearance on 2016-02-12, under 510(k) number K160092.

Who is the listed applicant for Digital Electrocardiograph?

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

What is the FDA product code for Digital Electrocardiograph?

The FDA product code for Digital Electrocardiograph 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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