CENTURION PROTECTIVE RESTRAINT, SCR SERIES— 510(k) K080448
Substantially EquivalentTri-State Hospital Supply Corp.
FDA 510(k) clearance K080448 for CENTURION PROTECTIVE RESTRAINT, SCR SERIES, Substantially Equivalent on 2008-08-28. Applicant: Tri-State Hospital Supply Corp..
Clearance details
- Applicant
- Tri-State Hospital Supply Corp.
- Product code
- Code FMQ
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Howell, MI, US
Adverse events under product code FMQ
product code FMQ- Death
- 8
- Total
- 8
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.