Soteria Bed Barrier— 510(k) K201876
Substantially EquivalentTrinity Guardion
FDA 510(k) clearance K201876 for Soteria Bed Barrier, Substantially Equivalent on 2022-09-01. Applicant: Trinity Guardion. Device class: 1.
Clearance details
- Applicant
- Trinity Guardion
- Product code
- Code QTV
- Device class
- Class 1
- Regulation
- 21 CFR 880.6190
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Batesville, IN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.