OHMEDA MEDICAL GIRAFFE INCUBATOR— 510(k) K020547
Substantially EquivalentOhmeda Medical
FDA 510(k) clearance K020547 for OHMEDA MEDICAL GIRAFFE INCUBATOR, Substantially Equivalent on 2002-05-09. 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
- Traditional
- 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 K020547
K-number listed on FDA's recall record- Z-2236-2020 — Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
- Z-1505-2017 — Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature controlled environment for the infant. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K020547.
Data sourced from openFDA. This site is unofficial and independent of the FDA.