FDA 510(k), K230214, Huma RPM (RPM)
FDA 510(k), K230214, Huma RPM (RPM)
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$149.00 USD
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$149.00 USD
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510(K) Number: K230214
Device Name: Huma RPM (RPM)
Manufacturer: Mani Shanmugham
Device Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Regulation Number: MWI
Classification Product Code: 01/26/2023
Date Received: 06/02/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: Huma RPM (RPM)
Manufacturer: Mani Shanmugham
Device Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Regulation Number: MWI
Classification Product Code: 01/26/2023
Date Received: 06/02/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular