Duns Number:079962037
Device Description: The Nihon Kohden Graphic User Interface is a display that is used with all NKV-550 Ventila The Nihon Kohden Graphic User Interface is a display that is used with all NKV-550 Ventilator configurations. The Graphical User Interface may be provided to users as a replacement or as a second Graphical User Interface.
Catalog Number
DSP5500A
Brand Name
Nihon Kohden
Version/Model Number
DSP5500A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 01, 2029
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
K181695
Product Code
CBK
Product Code Name
Ventilator, Continuous, Facility Use
Public Device Record Key
fb5e412b-3640-4dc5-988f-8d5211518235
Public Version Date
April 06, 2020
Public Version Number
1
DI Record Publish Date
March 27, 2020
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. | 5 |