INFINITY ETCO2 + RESPIRATORY MECHANICS POD— 510(k) K003550
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K003550 for INFINITY ETCO2 + RESPIRATORY MECHANICS POD, Substantially Equivalent on 2001-03-07. Applicant: Siemens Medical Solutions USA, Inc..
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code CCK
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Danvers, MA, US
Adverse events under product code CCK
product code CCK- Death
- 3
- Malfunction
- 11,428
- Total
- 11,431
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.