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Monitor, Breathing Frequency

FDA product code BZQ · Class 2 · Anesthesiology

975
Registered devices
127
Adverse events
3
Recalls
176
510(k) clearances

Devices with this code

Perfect Fit — DYMEDIX DIAGNOSTICS, INC.Perfect Fit — DYMEDIX DIAGNOSTICS, INC.PORTRAIT SpO2 P-SA01 — GE Healthcare Finland Oy1ST278-100 LuMon™ Belt Size 47 — SenTec AGCadwell — CADWELL INDUSTRIES, INC.BRAEBON Q-RIP Controller Output Cable — Braebon Medical CorporationNA — GE Medical Systems Information Technologies, Inc.NA — Conmed CorporationElastric Strap - Resp. EffortSleepmate — Ambu A/SThermiSense — SALTER LABSCARESCAPE B450 — GE Healthcare Finland OySleepmateCannula, Industry Standard CO2 — Ambu A/SSensor — Respironics, Inc.CONMED — Conmed CorporationPortrait CSSXB — GE Medical Systems Information Technologies, Inc.Perfect Fit — DYMEDIX DIAGNOSTICS, INC.SleepmateAC Model (snoring & flow), includes 5 Nasal + Cannulas — Ambu A/SCONMED — Conmed CorporationCadwell — CADWELL INDUSTRIES, INC.Perfect Fit — DYMEDIX DIAGNOSTICS, INC.Perfect Fit — DYMEDIX DIAGNOSTICS, INC.Perfect Fit — DYMEDIX DIAGNOSTICS, INC.Perfect Fit — DYMEDIX DIAGNOSTICS, INC.NA — GE Healthcare Finland Oy

Recent recalls

DateFirmReason
2010-12-21Salter Laboratories, Division of Regulatory AffairsThe incorrect length and connector were utilized in lot 110810 of the ThermiSense Alice 5, making the product unusable as it will not interface with the sleep l
2004-06-04Respironics, Inc.Recalling firm received a product complaint from a customer that the lead wire from Model 915 battery was not connected.
2004-05-24CAS Medical Systems, Inc.Device may not alarm for %SpO2 value limit violations if a specific feature is enabled

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