CENTURION PROTECTIVE RESTRAINT, SCR SERIES— 510(k) K080448

Name: FDA 510(k) clearance K080448
Creator: U.S. Food and Drug Administration
Published: 2008-08-28

Substantially Equivalent

Tri-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.. Device class: 1.

Clearance details

Applicant: Tri-State Hospital Supply Corp.
Product code: Code FMQ
Device class: Class 1
Regulation: 21 CFR 880.6760
Advisory panel: General Hospital
Date received: 2008-02-19
Decision date: 2008-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Howell, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FMQ

product code FMQ

Death: 8
Total: 8

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.