510(k) K201876
K201876 is an FDA 510(k) premarket notification submitted by Trinity Guardion for the device "Soteria Bed Barrier". The FDA issued a decision of Substantially Equivalent on September 1, 2022. The device falls under product code QTV (Mattress And Bed Deck Cover (Medical Purposes)), a Class I device regulated under 21 CFR 880.6190.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 1, 2022
- Date Received
- July 7, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mattress And Bed Deck Cover (Medical Purposes)
- Device Class
- Class I
- Regulation Number
- 880.6190
- Review Panel
- HO
- Submission Type
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.