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FDA 510(k)

BICARBONATE MIXING SYSTEM

K-Number: K864942 · 1987-03-10

ApplicantMorris Tool , Ltd.
Decision Date1987-03-10
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BICARBONATE MIXING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Morris Tool , Ltd.. It received FDA 510(k) clearance on 1987-03-10 under 510(k) number K864942. 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 BICARBONATE MIXING SYSTEM?

BICARBONATE MIXING SYSTEM is a medical device that received FDA 510(k) clearance on 1987-03-10. The listed applicant is Morris Tool , Ltd.. The 510(k) number is K864942.

When did BICARBONATE MIXING SYSTEM receive FDA 510(k) clearance?

BICARBONATE MIXING SYSTEM received FDA 510(k) clearance on 1987-03-10, under 510(k) number K864942.

Who is the listed applicant for BICARBONATE MIXING SYSTEM?

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

What is the FDA product code for BICARBONATE MIXING SYSTEM?

The FDA product code for BICARBONATE MIXING SYSTEM 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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