SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO— 510(k) K031340
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K031340 for SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO, Substantially Equivalent on 2003-11-25. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code MHX
- 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 MHX
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view allAdverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
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.