Duns Number:531817906
Device Description: The smartheart is a personal, hand-held battery powered, 12 lead EGand rhythm strip device The smartheart is a personal, hand-held battery powered, 12 lead EGand rhythm strip device with Bluetooth connection. The smartheartacquires EGG data via attached electrodes. The smartheart transmits thedata in real-time to a suitable Bluetooth communication device forforwarding it to a remote location and a certified medical professionalcapable of interpreting the results.
Catalog Number
-
Brand Name
smartheart
Version/Model Number
3.3
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
K113514
Product Code
DXH
Product Code Name
Transmitters And Receivers, Electrocardiograph, Telephone
Public Device Record Key
7599ae3c-ef76-47af-bde9-12a7e0e5b8c2
Public Version Date
March 10, 2021
Public Version Number
2
DI Record Publish Date
January 06, 2019
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 |