CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA— 510(k) K861758

Substantially Equivalent

Life Design Systems, Inc.

FDA 510(k) clearance K861758 for CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA, Substantially Equivalent on 1986-07-14. Applicant: Life Design Systems, Inc..

Clearance details

Applicant: Life Design Systems, Inc.
Product code: Code BYE
Advisory panel: Anesthesiology
Date received: 1986-05-06
Decision date: 1986-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

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Adverse events under product code BYE

product code BYE

Death: 5
Total: 5

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.