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FDA product code BTY · Class 2 · Anesthesiology

202
Registered devices
136
Adverse events
4
Recalls
63
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2017-08-15NDDd Medical Technologies, Inc.The CO/CO2 sensor cable harness may have lower electromagnetic shielding, which might have resulted in a non-compliance with the IEC 60601-1-2 standard. As a c
2017-08-15NDDd Medical Technologies, Inc.The CO/CO2 sensor cable harness may have lower electromagnetic shielding, which might have resulted in a non-compliance with the IEC 60601-1-2 standard. As a c
2014-12-23Shape Medical Systems, IncThis recall has been initiated because use of the impacted DPIs could result in erroneous testing results potentially leading to incorrect diagnosis and incorre
2014-05-28Shape Medical Systems, IncShape Medical has initiated a correction due to a mandatory software upgrade for the Shape HF Cardiopulmonary Testing System prior to use of the impacted DPI lo

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