FDA.reportPublic FDA data

Digital Electrocardiograph

Primary DI
06937683413879
Brand
Digital Electrocardiograph
Company
Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
Model
iE10
Published
2018-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171517000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171517000Digital ElectrocardiographBiocare Bio-Medical Equipment Co., Ltd.2018-01-11DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06937683413879PackageGS11In Commercial Distribution
06937683413855PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06937683413879069376834138796937683413879
06937683413855069376834138556937683413855

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, multichannelA device intended to be used by a healthcare professional in a clinical setting to record the electrical activity of the heart and display it in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed to record the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel). It may be intended for use while the patient is at rest (rest ECG) and/or during physical exercise (stress/exercise ECG), and may include a variety of additional features [e.g., interpretive software, data telemetry, display screen]; electrodes may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529081176
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06937683402019Digital ElectrocardiographECG-20002016-12-16
06937683413855Digital ElectrocardiographiE102018-01-30
06937683411448Digital ElectrocardiographiE1012016-10-18
06937683411530Digital ElectrocardiographiE 12A2016-10-18
06937683412346Digital ElectrocardiographiE32016-10-18
06937683412377Digital ElectrocardiographiE3002016-10-18
06937683412520Digital ElectrocardiographECG-30102016-10-18
06937683413022Digital ElectrocardiographiE122016-10-18
06937683413329Digital ElectrocardiographECG-12102016-10-18
06937683414319Digital ElectrocardiographiE62016-10-18
06937683415125Digital ElectrocardiographiE152016-10-18
06937683443128Doppler Fetal Heart Rate DetectorFM-2002016-10-18
06937683490092Digital ElectrocardiographECG-20002016-12-16

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