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The PHOENIX Neonatal Phototherapy Unit CFL 101 provides light therapy for the treatment of hyperbilirubinemia, commonly light therapy for and jaundice, during the newborn period in the hospital.

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This is a letter acknowledging receipt of a 510(k) premarket notification for the PHOENIX Neonatal Phototherapy Unit CFL 101. It states the device is substantially equivalent to legally marketed predicate devices and can proceed to market. There is no information in the provided text about acceptance criteria or a study proving the device meets those criteria. The letter and associated forms are for administrative purposes related to FDA clearance, not for presenting performance data.

Therefore, I cannot provide the requested information from the given text.

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The PHOENIX Infant Radiant Warmer consists of an infrared heating element placed over an infant in order to maintain the infant's body temperature at a level determined by the caregiver by means of radiant heat. It is designed to be used in those areas of the health care facility that provide neonatal and infant care.

The PHOENIX Infant Radiant Warmer consists of an infrared heating element placed over an infant in order to maintain the infant's body temperature at a level determined by the caregiver by means of radiant heat.

The provided text is a 510(k) premarket notification letter from the FDA regarding the PHOENIX Infant Radiant Warmer, Model 100NWS. This document provides regulatory information and approval for marketing the device, but it does not contain any information about acceptance criteria, study details, performance metrics, ground truth, or sample sizes.

Therefore, I cannot fulfill your request for the detailed technical information regarding the device's performance, studies, and ground truth establishment based on the provided text. The document is strictly a regulatory communication for market approval.

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