Duns Number:316584937
Device Description: The seca 115 PC software is for administering weight, height, bioimpedance and vital measu The seca 115 PC software is for administering weight, height, bioimpedance and vital measurements and for calculating automatically parameters such as FMI (fat mass index) which can be derived from these measurements. Results are displayed in graphical form and provide support with the following medical issues:• Documentation of weight changes• Documentation of energy expenditure and energy reserves• Documentation of cardiometabolic risk• Documentation of metabolic activity and the success of a training program, e.g. within the framework of rehabilitation or physiotherapy• Documentation of a patient’s fluids status and documentation of changes in fluids• Documentation of changes in vital signs
Catalog Number
1151306010
Brand Name
seca analytics 115
Version/Model Number
115
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
-
Product Code
NSX
Product Code Name
Software, transmission and storage, patient data
Public Device Record Key
d37b5adb-ce84-4b20-b6cf-f186664475de
Public Version Date
November 08, 2018
Public Version Number
2
DI Record Publish Date
August 15, 2018
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 109 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 29 |
| U | Unclassified | 3 |