FDA Product Code QTV: Mattress And Bed Deck Cover (medical Purposes)
A Mattress And Bed Deck Cover For Medical Purposes Is Intended To Provide A Physical Barrier Between The Patient And The Mattress As Well As All Or Parts Of The Bed Deck Or Frame.
Leading manufacturers include Trinity Guardion.
1
Total
1
Cleared
786d
Avg days
2022
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Mattress And Bed Deck Cover (medical Purposes) Devices (Product Code QTV)
1 devices
About Product Code QTV - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QTV since 2022, with 1 receiving FDA clearance (average review time: 786 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.