Duns Number:752905877
Device Description: Electric treatment chair for use in dialysis, day surgery and oncology applications design Electric treatment chair for use in dialysis, day surgery and oncology applications designed to accommodate bariatric patients. The chair can be used for patients up to weight not exceeding 300kg ( 660 lb).
Catalog Number
-
Brand Name
Fresenius Medical Care
Version/Model Number
T600B
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
August 30, 2024
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K091727
Product Code
INO
Product Code Name
Chair, Positioning, Electric
Public Device Record Key
8a8b8bdb-036e-4bd1-90a5-550b0f41648b
Public Version Date
August 26, 2019
Public Version Number
1
DI Record Publish Date
August 16, 2019
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. | 4 |