Isolette 8000 Plus— 510(k) K182977
Substantially EquivalentDraeger Medical Systems, Inc.
FDA 510(k) clearance K182977 for Isolette 8000 Plus, Substantially Equivalent on 2018-11-21. Applicant: Draeger Medical Systems, Inc..
Clearance details
- Applicant
- Draeger Medical Systems, Inc.
- Product code
- Code FMZ
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Telford, PA, US
Adverse events under product code FMZ
product code FMZ- Death
- 2
- Malfunction
- 457
- Other
- 1
- Total
- 460
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.