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FDA 510(k)

HEMODIALYSIS CONCENTRATE SOLUTION

K-Number: K792513 · 1980-04-08

ApplicantMid Atlantic Nephrology Center
Decision Date1980-04-08
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMODIALYSIS CONCENTRATE SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Mid Atlantic Nephrology Center. It received FDA 510(k) clearance on 1980-04-08 under 510(k) number K792513. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMODIALYSIS CONCENTRATE SOLUTION?

HEMODIALYSIS CONCENTRATE SOLUTION is a medical device that received FDA 510(k) clearance on 1980-04-08. The listed applicant is Mid Atlantic Nephrology Center. The 510(k) number is K792513.

When did HEMODIALYSIS CONCENTRATE SOLUTION receive FDA 510(k) clearance?

HEMODIALYSIS CONCENTRATE SOLUTION received FDA 510(k) clearance on 1980-04-08, under 510(k) number K792513.

Who is the listed applicant for HEMODIALYSIS CONCENTRATE SOLUTION?

The FDA 510(k) record lists Mid Atlantic Nephrology Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMODIALYSIS CONCENTRATE SOLUTION?

The FDA product code for HEMODIALYSIS CONCENTRATE SOLUTION is KPO.

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Related Devices (Code: KPO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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