S7 ELITE AND AUTOSET SPIRIT CPAP SYSTEMS WITH RESLINK— 510(k) K024191

Substantially Equivalent

Resmed, Ltd.

FDA 510(k) clearance K024191 for S7 ELITE AND AUTOSET SPIRIT CPAP SYSTEMS WITH RESLINK, Substantially Equivalent on 2003-07-02. Applicant: Resmed, Ltd..

Clearance details

Applicant: Resmed, Ltd.
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2002-12-20
Decision date: 2003-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Poway, CA, US

Download summary PDF View on FDA.gov ↗

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.