Air-Shields, Inc.
United StatesFDA applicant, unverified
- Devices
- 33
What Air-Shields, Inc. makes
Air-Shields, Inc. manufactures medical devices for neonatal and obstetric care, including infant incubators, radiant warmers, phototherapy systems, and patient monitoring solutions. Their portfolio includes ventilators for pediatric and neonatal use, fetal monitoring systems, and systems for managing obstetric patient data. The company also produces warming devices for delivery and birthing rooms, as well as infant scales and intensive care systems for vertical height adjustment.
The company’s devices are regulated under the FDA’s 510(k) pathway and fall into Class I and Class II categories. Their products are listed in the FDA’s 510(k) clearance registry, with some devices designated for critical neonatal and obstetric applications. The manufacturer is based in the United States.
Catalogue
Search and filter all 33 devicesFrequently asked questions
How many devices does Air-Shields, Inc. have in the registry?
The registry currently lists 33 devices for Air-Shields, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Air-Shields, Inc.'s devices?
Among its 33 most recently registered devices, Air-Shields, Inc. has devices listed in FDA 510(k) (33 devices).
What risk classes do Air-Shields, Inc.'s devices fall under?
Among its 33 most recently registered devices, the classes recorded for Air-Shields, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Air-Shields, Inc. in the registry?
The most recently registered devices listed for Air-Shields, Inc. include INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUS, WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM, ISOLETTE INCUBATOR and DUO-LITE PHOTOTHERAPY SYSTEM.