Air-Shields Vickers, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
What Air-Shields Vickers, Inc. makes
Air-Shields Vickers, Inc. manufactures neonatal medical devices, including infant incubators with transparent hoods and humidifiers, such as the Dewette 2 Isolette and Solair Infant Incubator. Their portfolio also covers phototherapy systems for newborns, oxygen controllers and monitors like the OxyCare, and accessories for incubators, including mounting rails and adjustable shelves. These products are designed for use in neonatal intensive care units to support temperature regulation, oxygen therapy, and light treatment for infants.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. Their products are intended for use in the United States, where they are subject to compliance with FDA requirements for medical devices. No additional international registries or classifications are specified.
Catalogue
Air-Shields Micro-Lite Phototherapy System Ref K912908
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Dewette 2 Isolette Incubator Humidifier Ref K924297
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Oxycare(Tm) Oxygen Controller/Monitor Ref K924679
Regimes: 510(k) Registry: 510(k)Neonatal Incubator (Accessory) Ref K895782
Regimes: 510(k) Registry: 510(k)C100 Infant Incubator Shelf/Mount Rail System Ref K912910
Regimes: 510(k) Registry: 510(k)Model C286 Isolette Infant Incubator Ref K903378
Regimes: 510(k) Registry: 510(k)C100 Qt Variable Height Adjustment Incubator Ref K884086
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Air-Shields Vickers, Inc. have in the registry?
The registry currently lists 9 devices for Air-Shields Vickers, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Air-Shields Vickers, Inc.'s devices?
Among its 9 most recently registered devices, Air-Shields Vickers, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Air-Shields Vickers, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Air-Shields Vickers, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Air-Shields Vickers, Inc. in the registry?
The most recently registered devices listed for Air-Shields Vickers, Inc. include AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEM, AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST, DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER and SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM.