Neonatal Incubator (Accessory)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K895782 ↗

FDA Product Code

FMZ

Device Class

Class II

Regulation

21 CFR Part 880.5400

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Air-Shields Vickers, Inc. →

• What is the purpose of the Neonatal Incubator Accessory?

  The Neonatal Incubator Accessory is a rigid boxlike enclosure that maintains a controlled environment for infant medical care. It includes an AC-powered heater, a fan for air circulation, a water container for humidity, and an oxygen control valve to provide optimal conditions for neonatal patients.

• How is the Neonatal Incubator Accessory supplied and what is its regulatory status?

  This device is supplied as an accessory and is regulated under FDA 510(k) clearance K895782 with a product code FMZ. It is classified as a class II device for general hospital use and was cleared on December 7, 1989, as substantially equivalent.

• What components are included with the Neonatal Incubator Accessory?

  The Neonatal Incubator Accessory includes an AC-powered heater, a fan for air circulation, a water container for humidity control, and an oxygen control valve. It also features access ports for nursing care to facilitate medical procedures while maintaining the controlled environment.

• Is the Neonatal Incubator Accessory reusable or single-use?

  The device data does not specify whether the Neonatal Incubator Accessory is designed for single-use or reuse. For specific information regarding reusability, please consult the manufacturer's instructions or contact Air-Shields Vickers, Inc. directly.