Soteria Bed Barrier
FDA 510(k) clearance K201876 · decided 2022-09-01
Clearance details
- K-number
- K201876
- Device name
- Soteria Bed Barrier
- Applicant
- Trinity Guardion
- Decision
- Substantially Equivalent
- Date received
- 2020-07-07
- Decision date
- 2022-09-01
- Days to decision
- 786 days
- Clearance type
- Traditional
- Product code
- QTV
- Device class
- 1
- Regulation number
- 880.6190
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Batesville, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.