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510(k) Data Aggregation
K Number
K123816Device Name
DIGITAL ELECTROCARDIOGRAPHS
Manufacturer
SHENZHEN BIOCARE ELECTRONICS CO., LTD
Date Cleared
2013-02-27
(77 days)
Product Code
DPS
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN BIOCARE ELECTRONICS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Digital Electrocardiographs, iE 12A / iE 15S, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Device Description
Digital Electrocardiographs, iE 12A / iE 15 / iE 15S, are designed to acquire, display and record ECG signals from patient body surface by ECG electrodes. After been amplified and filtered, the ECG signals waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data result and patient information could be stored in the memory of the device.
All the models. iE 12A / iE 15 / iE 15S, of the proposed device. Digital Electrocardiographs, follow · the same design principle and similar technical specifications.
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K Number
K122712Device Name
DIGITAL ELECTROCARDIOGRAPH
Manufacturer
SHENZHEN BIOCARE ELECTRONICS CO., LTD
Date Cleared
2012-10-25
(51 days)
Product Code
DPS
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN BIOCARE ELECTRONICS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Digital Electrocardiographs, ECG-8080/ iE 3S/ iE 12/ iE 12P, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Device Description
Digital Electrocardiographs, ECG-8080/ IE 3S/ iE 12/ iE 12P, are designed to acquire, display and record ECG signals from patient body surface by ECG electrodes. After been amplified and filtered, the ECG signals waveforms are displayed in the LCD and recorded in the paperthrough thermal printer. ECG data result and patient information could be stored in the memory of the device.
All the models, ECG-8080/ iE 3S/ iE 12/ iE 12P, of the proposed device, Digital Electrocardiographs, follow the same design principle and similar technical specifications.
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K Number
K112431Device Name
DIGITAL ELECTROCARDIOGRAPH
Manufacturer
SHENZHEN BIOCARE ELECTRONICS CO., LTD
Date Cleared
2011-09-22
(30 days)
Product Code
DPS
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN BIOCARE ELECTRONICS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Digital Electrocardiographs, ECG-3020 / ECG-3030 / ECG-3060 / ECG-6020 / ECG-1220 / ECG-1260 / ECG-1215 / ECG-1216, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Device Description
Digital Electrocardiographs, ECG-3020 / ECG-3030 / ECG-3060 / ECG-6020 / ECG-1220 / ECG-1260 / ECG-1215 / ECG-1216, are designed to acquire, display and record ECG signals from patient body surface by ECG electrodes. After been amplified and filtered, the ECG signals waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data result and patient information could be stored in the memory of the device.
All the models, ECG-3020 / ECG-3030 / ECG-3060 / ECG-6020 / ECG-1220 / ECG-1260 / ECG-1215 / ECG-1216, of the proposed device, Digital Electrocardiographs, follow the same design principle and similar technical specifications.
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K Number
K101876Device Name
DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010
Manufacturer
SHENZHEN BIOCARE ELECTRONICS CO., LTD
Date Cleared
2011-03-01
(238 days)
Product Code
DPS
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN BIOCARE ELECTRONICS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Digital Electrocardiographs, ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Device Description
Digital Electrocardiographs, ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010, are designed to acquire, display and record ECG signals from patient body surface by ECG electrodes. After been amplified, filtered, the ECG signals waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data and patient information could be stored in the memory of the device. All the models, ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010, of the proposed device, Digital Electrocardiographs, follow the same design principle and same technical specifications: They consist of four modules, which are power supply module, signal collection module, amplification module, and control module.
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K Number
K100626Device Name
DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200
Manufacturer
SHENZHEN BIOCARE ELECTRONICS CO., LTD
Date Cleared
2010-05-21
(77 days)
Product Code
KNG, REG
Regulation Number
884.2660Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN BIOCARE ELECTRONICS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FM-200 Doppler Fetal Heart Rate Detector is a hand-held, battery powered Doppler devices used for detecting fetal heart beats.
Device Description
Doppler fetal heart rate detector is a portable equipment to detect the heart rate of fetus in Obstetrics & Gynecology and delivery room. It can also be used at home or in public place for prenatal diagnosis on pregnant women. Doppler fetal heart rate detector is composed of the parts used for ultrasonic signal emitting and receiving, simulating signal processing, fetal heart rate calculation and display control.
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