Duns Number:368788568
Device Description: Planmeca Chair is electronically controlled patient chair with swivel funcion allowing the Planmeca Chair is electronically controlled patient chair with swivel funcion allowing the chair to be swivelled 90 degrees to left and right. The chair has an integrated foot control for automatic chair positions and manual movements. The chair can be equipped with optional foldable knee-break.
Catalog Number
10026000
Brand Name
Planmeca Chair
Version/Model Number
Chair
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K923534
Product Code
KLC
Product Code Name
Chair, Dental, With Operative Unit
Public Device Record Key
0346cf77-4329-45ca-9373-05887c200dbb
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 08, 2017
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |