FLOW GENERATOR FOR SLEEP APNEA, LDS 1500— 510(k) K862448

Substantially Equivalent

Life Design Systems, Inc.

FDA 510(k) clearance K862448 for FLOW GENERATOR FOR SLEEP APNEA, LDS 1500, Substantially Equivalent on 1986-11-14. Applicant: Life Design Systems, Inc..

Clearance details

Applicant: Life Design Systems, Inc.
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 1986-06-27
Decision date: 1986-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

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Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

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.