Duns Number:081290845
Device Description: Healthbot (HCLK-2000) is intended for use by the general public to measure blood pressure, Healthbot (HCLK-2000) is intended for use by the general public to measure blood pressure, pulse and body weight. . It is not a diagnostic device. The user can choose to store or send the data to a healthcare professional.
Catalog Number
-
Brand Name
Healthbot
Version/Model Number
HCK-2000
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K152107
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
9d364c14-57c2-4401-aa4b-2fc52984e6fe
Public Version Date
February 19, 2020
Public Version Number
1
DI Record Publish Date
February 11, 2020
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 |