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FDA 510(k)

GAMBRO BICART 720G

K-Number: K940601 · 1994-03-22

ApplicantC.G.H. Medical, Inc.
Decision Date1994-03-22
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMBRO BICART 720G is the device name listed in this FDA 510(k) record. The listed applicant is C.G.H. Medical, Inc.. It received FDA 510(k) clearance on 1994-03-22 under 510(k) number K940601. 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 GAMBRO BICART 720G?

GAMBRO BICART 720G is a medical device that received FDA 510(k) clearance on 1994-03-22. The listed applicant is C.G.H. Medical, Inc.. The 510(k) number is K940601.

When did GAMBRO BICART 720G receive FDA 510(k) clearance?

GAMBRO BICART 720G received FDA 510(k) clearance on 1994-03-22, under 510(k) number K940601.

Who is the listed applicant for GAMBRO BICART 720G?

The FDA 510(k) record lists C.G.H. Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAMBRO BICART 720G?

The FDA product code for GAMBRO BICART 720G is KPO.

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Other records listing C.G.H. Medical, Inc. as applicant

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K941708COBE CENTRYSYSTEM CS500 DIALYZERK933818GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTERK925522CENTRYSYSTEM 3 WITH CHARTS/BP OPTIONK920757FILTRAL HEMODIALYZERSK931720LUNDIA ALPHA 700 HEMODIALYZERK924437HEMOSPAL KIT B22 / MULTIFLOW 60 KIT

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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

View on FDA Database →

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

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