Digital Electrocardiograph

FDA 510(k) K152384 · Shenzhen Biocare Bio-Medical Equipment Co., Ltd.

Substantially Equivalent

510(k) numberK152384

Submission

Device name
Digital Electrocardiograph
Applicant
Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
Shenzhen, CN
Received
August 24, 2015
Decision date
December 18, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DPS – Electrocardiograph
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2340
Specialty
Cardiovascular

Other 510(k)s with product code DPS

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K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)DPS · Traditional Edan Instruments, Inc.07/02/2026SE
K251670MAC 7 Resting ECG Analysis SystemDPS · Traditional Ge Medical Systems Information Technologies, Inc.01/26/2026SE
K252361AccurECG Analysis System (v2.0)DPS · Traditional Accurkardia, Inc.12/22/2025SE
K252474Withings BeamO (SCT02)DPS · Traditional Withings11/10/2025SE
K250569Cardiologs Holter PlatformDPS · Traditional Philips France Commercial08/06/2025SE
K243252ZBPro DiagnosticDPS · Traditional Zbeats, Inc.07/10/2025SE
K243305Masimo W1DPS · Traditional Masimo Corporation04/03/2025SE
K241217CloudHRV™ System (100-01-001)DPS · Traditional Inmedix, Inc.01/16/2025SE
K241556Cardiac Workstation (5000); Cardiac Workstation (7000)DPS · Traditional Philips Medizin Systeme Böblingen GmbH12/17/2024SE
K240229Masimo W1DPS · Traditional Masimo Corporation08/08/2024SE

More from Masimo Corporation

510(k)DeviceDecision
K160092Digital ElectrocardiographDPS · Special 02/12/2016SE
K141946Digital ElectrocardiographDPS · Traditional 02/13/2015SE
K133985Digital ElectrocardiographDPS · Traditional 01/22/2015SE
K132758Digital ElectrocardiographDPS · Special 01/30/2014SE

Questions and answers

When was Digital Electrocardiograph cleared by the FDA?

Digital Electrocardiograph (K152384) received a 510(k) decision of Substantially Equivalent on December 18, 2015, 116 days after the submission was received.

What is the product code of K152384?

The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.