Icor AB
SwedenFDA applicant, unverified
- Devices
- 16
What Icor AB makes
Icor AB manufactures respiratory support devices for neonatal and pediatric patients, including high-frequency oscillatory ventilators (HCH 4, HCH 7), neonatal high-frequency jet ventilators (ICOR NEONATAL HCH), and endotracheal tube placement detectors (with Colibri indicator). The company also produces airway management tools such as flexible and standard endotracheal tubes (AFH, AFH-T, AFH/T FLEX), humidifiers (HumidAir I & II), and a breath-easy modification for airway support. Monitoring solutions include the Icor Agent Monitor and capnometry units (ICOR CMU Q Plus).
The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory clearance through the 510(k) pathway. Products are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Catalogue
Search and filter all 16 devicesFrequently asked questions
How many devices does Icor AB have in the registry?
The registry currently lists 16 devices for Icor AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Icor AB's devices?
Among its 16 most recently registered devices, Icor AB has devices listed in FDA 510(k) (16 devices).
What risk classes do Icor AB's devices fall under?
Among its 16 most recently registered devices, the classes recorded for Icor AB's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Icor AB in the registry?
The most recently registered devices listed for Icor AB include HEAT AND MOISTURE EXCHANGERS AND FILTERS, BREATH-EASY, ICOR NEONATAL HCH and FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE.