FDA.reportPublic FDA data

Emay

Primary DI
04897087200104
Brand
Emay
Company
EMAY (HK) LIMITED
Model
EMG-10
Device description
It's designed for family and individual users to track heart activity at home, at work or on a trip in case of cardiac situation that needs evaluation on the spot.
Published
2017-12-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152863000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152863000Portable ECG MonitorContec Medical Systems Co.,Ltd2016-06-22DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04897087200104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04897087200104048970872001044897087200104

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic monitorA mains electricity (AC-powered) bedside device designed to continuously detect, measure, and display a patient's electrocardiogram (ECG) through leads and sensors attached to the patient; it also typically displays heart rate. The device is typically equipped with audible and/or visual alarms that are triggered when the patient's parameters drop below or exceed pre-set limits.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
664020405
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04897087200401EMAYEMO-402019-11-25
04897087200609EMAYEMO-602022-12-15
04897087200906EMAYEMO-902022-12-15
04897087200302EMAYEMO-302019-11-25
04897087200036EMAYSleepO22021-07-09
04897087200807EMAYEMO-802019-11-29
04897087200203EmayEMG-202019-03-28
04897087206120EmayEMG-6L2023-11-15
04897087200098EMAYSleepO2 Pro2024-01-18
04897087201002EMAYEMO-1002024-01-08
04897087200012EmayEMT-012017-10-20
04897087201019EmayWT22017-08-04

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