Duns Number:054318779
Device Description: Body composition monitor with scale and Bluetooth and smart tracking of 6 body metrics.
Catalog Number
BCM-500
Brand Name
Omron Body Composition Monitor and Scale with Bluetooth
Version/Model Number
BCM-500
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K062043,K062043
Product Code
PUH
Product Code Name
Analyzer, Body Composition, Exempt
Public Device Record Key
d965f097-d54e-4c16-adb4-0f5ffcf0a185
Public Version Date
August 27, 2019
Public Version Number
1
DI Record Publish Date
August 19, 2019
Package DI Number
10073796233508
Quantity per Package
6
Contains DI Package
00073796233501
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |