SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM— 510(k) K964624
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K964624 for SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM, Substantially Equivalent on 1997-09-11. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code DSI
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Danvers, MA, US
Recent devices under product code DSI
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view allAdverse events under product code DSI
product code DSI- Death
- 170
- Injury
- 729
- Malfunction
- 10,680
- Total
- 11,579
Source: openFDA MAUDE database, through . 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.