SERVO VENTILATOR 300A— 510(k) K970839
Substantially Equivalent - Subject to Tracking Reg.Siemens Elema AB
FDA 510(k) clearance K970839 for SERVO VENTILATOR 300A, Substantially Equivalent - Subject to Tracking Reg. on 1997-10-14. Applicant: Siemens Elema AB.
Clearance details
- Applicant
- Siemens Elema AB
- Product code
- Code CBK
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- S-17195 Solna, SE
Adverse events under product code CBK
product code CBK- Death
- 736
- Injury
- 3,628
- Malfunction
- 98,786
- Other
- 4
- Total
- 103,154
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.