Devices

SmartMonitor 2 Infant Apnea Monitor

Model / Serial
Model Number 4002; Serial Numbers 3000033364 through 3000038740 and Model Number 4003; Serial Numbers 3000033364 through 3000038740.
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Canada.
Product Description
SmartMonitor 2 Infant Apnea Monitor. || The monitor is intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor detects and alarms for periods of central apnea and high or low heart rates.
Manufacturer
Respironics, Inc.
1 Event
- Recall of SmartMonitor 2 Infant Apnea Monitor

Manufacturer

Respironics, Inc.

Manufacturer Address
Respironics, Inc., 1001 Murry Ridge Ln, Murrysville PA 15668-8517
Manufacturer Parent Company (2017)
Philips
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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