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FDA 510(k), K132829, QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
FDA 510(k), K132829, QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
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510(K) Number: K132829
Device Name: QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
Manufacturer: WHITNEY TORNING
Device Classification Name: Oxygenator, Cardiopulmonary Bypass
Regulation Number: DTZ
Classification Product Code: KXA
Date Received: 09/09/2013
Decision Date: 10/08/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
Manufacturer: WHITNEY TORNING
Device Classification Name: Oxygenator, Cardiopulmonary Bypass
Regulation Number: DTZ
Classification Product Code: KXA
Date Received: 09/09/2013
Decision Date: 10/08/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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