FDA 510(k), K162131, ExSpiron 1Xi
FDA 510(k), K162131, ExSpiron 1Xi
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$149.00 USD
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510(K) Number: K162131
Device Name: ExSpiron 1Xi
Manufacturer: Edwin Rule
Device Classification Name: Spirometer, Monitoring (W/Wo Alarm)
Regulation Number: BZK
Classification Product Code: 08/01/2016
Date Received: 05/09/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: ExSpiron 1Xi
Manufacturer: Edwin Rule
Device Classification Name: Spirometer, Monitoring (W/Wo Alarm)
Regulation Number: BZK
Classification Product Code: 08/01/2016
Date Received: 05/09/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology