Duns Number:664020405
Device Description: It's designed for family and individual users to track heart activity at home, at work or 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.
Catalog Number
-
Brand Name
Emay
Version/Model Number
EMG-10
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2020
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K152863
Product Code
DPS
Product Code Name
Electrocardiograph
Public Device Record Key
c7375f86-073c-4201-bb1f-b3f03e824cb9
Public Version Date
December 31, 2020
Public Version Number
4
DI Record Publish Date
December 15, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |