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FDA 510(k), K193293, XV Lung Ventilation Analysis Software
FDA 510(k), K193293, XV Lung Ventilation Analysis Software
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$49.00 USD
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$49.00 USD
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510(K) Number: K193293
Device Name: XV Lung Ventilation Analysis Software
Manufacturer: Terrence Thiel
Device Classification Name: System, X-Ray, Tomography, Computed
Regulation Number: JAK
Classification Product Code: KXA
Date Received: 11/27/2019
Decision Date: 05/14/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: XV Lung Ventilation Analysis Software
Manufacturer: Terrence Thiel
Device Classification Name: System, X-Ray, Tomography, Computed
Regulation Number: JAK
Classification Product Code: KXA
Date Received: 11/27/2019
Decision Date: 05/14/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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