SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM— 510(k) K970920

Substantially Equivalent

Siemens Medical Solutions USA, Inc.

FDA 510(k) clearance K970920 for SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM, Substantially Equivalent on 1997-07-29. Applicant: Siemens Medical Solutions USA, Inc..

Clearance details

Applicant: Siemens Medical Solutions USA, Inc.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 1997-03-12
Decision date: 1997-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

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Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.