QTV — Mattress And Bed Deck Cover (Medical Purposes) Class I
FDA product code QTV covers "Mattress And Bed Deck Cover (Medical Purposes)", a Class I medical device regulated under 21 CFR 880.6190. Submissions are reviewed by the General Hospital panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QTV
- Device Class
- Class I
- Regulation Number
- 880.6190
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K201876 | trinity guardion | Soteria Bed Barrier | September 1, 2022 |