K201876 is an FDA 510(k) clearance for the Soteria Bed Barrier. This device is classified as a Mattress And Bed Deck Cover (medical Purposes) (Class I - General Controls, product code QTV).
Submitted by Trinity Guardion (Batesville, US). The FDA issued a Cleared decision on September 1, 2022, 786 days after receiving the submission on July 7, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.6190. 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..
| 510(k) Number | K201876 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2020 |
| Decision Date | September 01, 2022 |
| Days to Decision | 786 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QTV - Mattress And Bed Deck Cover (medical Purposes) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6190 |
| Definition | 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. |