PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905— 510(k) K972123

Substantially Equivalent

Smith

FDA 510(k) clearance K972123 for PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905, Substantially Equivalent on 1997-07-25. Applicant: Smith.

Clearance details

Applicant: Smith
Product code: Code FMQ
Advisory panel: General Hospital
Date received: 1997-06-05
Decision date: 1997-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, US

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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.