Giraffe OmniBed Carestation CS1— 510(k) K152814
Substantially EquivalentOhmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company
FDA 510(k) clearance K152814 for Giraffe OmniBed Carestation CS1, Substantially Equivalent on 2016-03-17. Applicant: Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company.
Clearance details
- Applicant
- Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company
- Product code
- Code FMZ
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Laurel, MD, 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.