Duns Number:103422838
Device Description: Multi-component device that connects to a user’s PC computer for measurement, tracking, an Multi-component device that connects to a user’s PC computer for measurement, tracking, and reporting of body weight and blood pressure. Device consists of a stand-on body weight scale, non-invasive automatic blood pressure monitor, analog to digital interface unit (CTI), and software (to be installed on the user’s PC computer).
Catalog Number
-
Brand Name
MicroFit
Version/Model Number
FAS-2
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
K830003
Product Code
DXG
Product Code Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Public Device Record Key
9044dc26-18e3-460b-8978-3bafc6254d0a
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
September 26, 2016
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 |