Duns Number:080381900
Device Description: The hom ecg+ / AfibAlert® is a cardiac event recorder capable of recording and storing ap
Catalog Number
790.102.200
Brand Name
AfibAlert / hom ecg+
Version/Model Number
V2.0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K052767
Product Code
DXH
Product Code Name
Transmitters And Receivers, Electrocardiograph, Telephone
Public Device Record Key
0b8c343b-1344-4f91-81e7-c4b358770256
Public Version Date
October 05, 2022
Public Version Number
1
DI Record Publish Date
September 27, 2022
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. | 1 |