SBS MODEL 1615— 510(k) K924565

Substantially Equivalent

Stand-By-Systems, Inc.

FDA 510(k) clearance K924565 for SBS MODEL 1615, Substantially Equivalent on 1994-09-09. Applicant: Stand-By-Systems, Inc..

Clearance details

Applicant: Stand-By-Systems, Inc.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 1992-09-09
Decision date: 1994-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAW

product code CAW

Death: 204
Injury: 573
Malfunction: 1,400
Other: 6
Total: 2,183

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.