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510(k) Data Aggregation
K Number
K190494Device Name
Infant Incubator
Manufacturer
Ningbo David Medical Device Co.,Ltd
Date Cleared
2019-11-25
(270 days)
Product Code
FMZ, FMT, REG
Regulation Number
880.5400Why did this record match?
Applicant Name (Manufacturer) :
Ningbo David Medical Device Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is an infant incubator and an infant warmer. The two functions can be converted through the canopy lifting system. The incubator provides an enclosed, temperature-controlled environment and the warmer provides infrared heat in an open environment. The warmer provides heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. The incubator and warmer may also be used for short periods of time to facilitate a neonate's transition from the uterus to the external environment.
Device Description
The YP-3000 has the functions of an infant incubator and an infant radiant warmer. The infant radiant warmer is optional, the two functions can be converted through the canopy lifting system. For the infant incubator, the temperature control system implements servo control on the temperature in the incubator (air temperature / skin temperature) and the device performs proportional heating control based on the setting of the temperature and the actual measured temperature. The internal air is adjusted through thermal convection to create an environment with proper temperature and humidity for infant incubation. It is intended to be used for constant temperature incubation of low birth weight infants, critically sick babies and neonates, as well as neonatal body temperature resuscitation, transfusion, oxygen therapy, emergency treatment, and hospitalization for neonates. The Infant radiant warmer transfers heat to the patient from the infrared radiation heating source through the parabolic reflecting hood transmitting heat to the patient on the mattress. proportional heating is controlled based on actual skin temperature. The device is equipped with a mattress, an electronic scale, and an oxygen control system. Other accessories include an observation lamp, tray, and an IV pole.
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