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FDA 510(k)

Isopure Dry Acid Dissolution System

N.º K: K191093 · 2020-01-22

SolicitanteIsopure, Corp.
Fecha de decisión2020-01-22
Código de productoKPO
Comité asesorGU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Isopure Dry Acid Dissolution System is the device name listed in this FDA 510(k) record. The listed applicant is Isopure, Corp.. It received FDA 510(k) clearance on 2020-01-22 under 510(k) number K191093. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Isopure Dry Acid Dissolution System?

Isopure Dry Acid Dissolution System is a medical device that received FDA 510(k) clearance on 2020-01-22. The listed applicant is Isopure, Corp.. The 510(k) number is K191093.

When did Isopure Dry Acid Dissolution System receive FDA 510(k) clearance?

Isopure Dry Acid Dissolution System received FDA 510(k) clearance on 2020-01-22, under 510(k) number K191093.

Who is the listed applicant for Isopure Dry Acid Dissolution System?

The FDA 510(k) record lists Isopure, Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Isopure Dry Acid Dissolution System?

The FDA product code for Isopure Dry Acid Dissolution System is KPO.

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Dispositivos relacionados (Código: KPO)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, IncoporatedK253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)Fresenius Medical Care Renal Therapies Group, LLCK252180Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)Fresenius Medical Care Renal Therapies Group, LLCK243786Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)Fresenius Medical Care Renal Therapies Group, LLCK240920HemoCare Bicarbonate Concentrate Set (BCS)Deka Research and DevelopmentK233950pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)Fresenius Medical Care Renal Therapies Group, LLC

Fuente oficial

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