Duns Number:544312126
Device Description: LCD Monitor
Catalog Number
-
Brand Name
Hisense
Version/Model Number
HMD3C21S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K221567
Product Code
PGY
Product Code Name
Display, Diagnostic Radiology
Public Device Record Key
425cfd34-2c11-49b9-99a7-02cc88f2e7df
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
September 13, 2022
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. | 65 |