SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION— 510(k) K062793
Substantially EquivalentMaquet Critical Care AB
FDA 510(k) clearance K062793 for SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION, Substantially Equivalent on 2007-02-07. Applicant: Maquet Critical Care AB.
Clearance details
- Applicant
- Maquet Critical Care AB
- Product code
- Code CBK
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bridgewater, NJ, US
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.