GIRAFFE INCUBATOR— 510(k) K101778
Substantially EquivalentOhmeda Medical
FDA 510(k) clearance K101778 for GIRAFFE INCUBATOR, Substantially Equivalent on 2010-07-21. Applicant: Ohmeda Medical. Device class: 2.
Clearance details
- Applicant
- Ohmeda Medical
- Product code
- Code FMZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5400
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Laurel, MD, US
Recent devices under product code FMZ
view allMore clearances from Ohmeda Medical
view allAdverse 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 →
Recalls naming K101778
K-number listed on FDA's recall record- Z-2236-2020 — Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
- Z-1051-2013 — Giraffe OmniBed¿ and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. GE Healthcare Giraffe Omnibed is a combination of an infant incubator and an infant warmer.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101778.
Data sourced from openFDA. This site is unofficial and independent of the FDA.