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

510(K) Number: K152384
Device Name: Digital Electrocardiograph
Manufacturer: Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
Device Classification Name: electrocardiograph
Regulation Number: 870.2340
Classification Product Code: DPS
Date Received: 08/24/2015
Decision Date: 12/18/2015
Regulation Medical Specialty: Cardiovascular