DECUBITUS MATTRESS— 510(k) K760963

Substantially Equivalent

Arco Medical Products Co.

FDA 510(k) clearance K760963 for DECUBITUS MATTRESS, Substantially Equivalent on 1976-11-18. Applicant: Arco Medical Products Co..

Clearance details

Applicant: Arco Medical Products Co.
Product code: Code IKY
Advisory panel: General Hospital
Date received: 1976-11-04
Decision date: 1976-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IKY

product code IKY

Death: 5
Malfunction: 491
Other: 4
Total: 500

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.