FDA 510(k), K230632, VersiHD with GuideMe software

FDA 510(k), K230632, VersiHD with GuideMe software

Regular price $149.00 USD
Regular price Sale price $149.00 USD
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510(K) Number: K230632
Device Name: VersiHD with GuideMe software
Manufacturer: Denise Oppermann
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: KDI
Classification Product Code: 03/07/2023
Date Received: 08/11/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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