Class I Medical Device Recall: Respironics, Inc., SmartMonitor 2 Infant Apnea Monitor (Models 4002 and 4003) at Regulatory Affairs Syndicator

Class I Medical Device Recall: Respironics, Inc., SmartMonitor 2 Infant Apnea Monitor (Models 4002 and 4003)

Published by CDRH Consumer News May 17th, 2009 in Regulatory Affairs

This device is used for the continuous monitoring of respiration and heart rate of infant patients in the home or in the hospital. The monitor detects and alarms for periods of temporary interruption of breathing (central apnea) or low heart rates.

Regulatory Affairs Syndicator

Class I Medical Device Recall: Respironics, Inc., SmartMonitor 2 Infant Apnea Monitor (Models 4002 and 4003)

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