FDA 510(k), K181660, Acapella Choice Blue Vibratory PEP Device
FDA 510(k), K181660, Acapella Choice Blue Vibratory PEP Device
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$149.00 USD
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$149.00 USD
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510(K) Number: K181660
Device Name: Acapella Choice Blue Vibratory PEP Device
Manufacturer: Donna Semlak
Device Classification Name: Spirometer, Therapeutic (Incentive)
Regulation Number: BWF
Classification Product Code: 06/25/2018
Date Received: 10/24/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: Acapella Choice Blue Vibratory PEP Device
Manufacturer: Donna Semlak
Device Classification Name: Spirometer, Therapeutic (Incentive)
Regulation Number: BWF
Classification Product Code: 06/25/2018
Date Received: 10/24/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology