QTV
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Mattress And Bed Deck Cover (Medical Purposes)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6190
- Medical specialty
- General Hospital
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Soteria Bed Barrier (K201876) | Trinity Guardion | 2022-09-01 |
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Every clearance here is in the API, with alerts when new ones post.