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FDA 510(k)

Rockwell Medical CitraPure Concentrado de Ácido

N.º K: K160847 · 2016-10-20

SolicitanteRockwell Medical
Fecha de decisión2016-10-20
Código de productoKPO
Comité asesorGU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Rockwell Medical CitraPure Acid Concetrate is the device name listed in this FDA 510(k) record. The listed applicant is Rockwell Medical. It received FDA 510(k) clearance on 2016-10-20 under 510(k) number K160847. 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 Rockwell Medical CitraPure Acid Concetrate?

Rockwell Medical CitraPure Acid Concetrate is a medical device that received FDA 510(k) clearance on 2016-10-20. The listed applicant is Rockwell Medical. The 510(k) number is K160847.

When did Rockwell Medical CitraPure Acid Concetrate receive FDA 510(k) clearance?

Rockwell Medical CitraPure Acid Concetrate received FDA 510(k) clearance on 2016-10-20, under 510(k) number K160847.

Who is the listed applicant for Rockwell Medical CitraPure Acid Concetrate?

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

What is the FDA product code for Rockwell Medical CitraPure Acid Concetrate?

The FDA product code for Rockwell Medical CitraPure Acid Concetrate 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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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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