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Monitor, Apnea, Facility Use

FDA product code FLS · Class 2 · Anesthesiology

2
Registered devices
620
Adverse events
2
Recalls
16
510(k) clearances

Devices with this code

SmartMonitor 2 w/ Modem — CIRCADIANCE, LLCSmartMonitor 2 w/o Modem — CIRCADIANCE, LLC

Recent recalls

DateFirmReason
2009-04-23Respironics, Inc.Audible alarm failure.
2007-10-15Respironics, Inc.Foreign material: Glass fragments may present in the plastic bag material used to ship components.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.