Duns Number:141647094
Device Description: FedMedMicFiP, with polarised filter, is a small and portable digital dermatoscope with Wi- FedMedMicFiP, with polarised filter, is a small and portable digital dermatoscope with Wi-Fi transmission. Using proper SW and Apps you can take pictures and video using PC, smartphones or tablets.
Catalog Number
BTS-300
Brand Name
WI-FI DERMATOSCOPE POLARISED FILTER
Version/Model Number
BTS-300
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 30, 2022
Issuing Agency
In HIBCC
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"
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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
ERA
Product Code Name
Otoscope
Public Device Record Key
4c323a1c-4c21-4378-b25a-b851d22625b3
Public Version Date
May 02, 2022
Public Version Number
2
DI Record Publish Date
August 18, 2021
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 | 34 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |