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FDA 510(k)

RENAPAK CONCENTRATE MIXING SYS.

K-Number: K840182 · 1984-05-02

ApplicantRenal Systems, Inc.
Decision Date1984-05-02
Product CodeFKQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RENAPAK CONCENTRATE MIXING SYS. is the device name listed in this FDA 510(k) record. The listed applicant is Renal Systems, Inc.. It received FDA 510(k) clearance on 1984-05-02 under 510(k) number K840182. The device is classified under product code FKQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RENAPAK CONCENTRATE MIXING SYS.?

RENAPAK CONCENTRATE MIXING SYS. is a medical device that received FDA 510(k) clearance on 1984-05-02. The listed applicant is Renal Systems, Inc.. The 510(k) number is K840182.

When did RENAPAK CONCENTRATE MIXING SYS. receive FDA 510(k) clearance?

RENAPAK CONCENTRATE MIXING SYS. received FDA 510(k) clearance on 1984-05-02, under 510(k) number K840182.

Who is the listed applicant for RENAPAK CONCENTRATE MIXING SYS.?

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

What is the FDA product code for RENAPAK CONCENTRATE MIXING SYS.?

The FDA product code for RENAPAK CONCENTRATE MIXING SYS. is FKQ.

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Other records listing Renal Systems, Inc. as applicant

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.

K970648PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)K861730ACTRIL FOR KIDNEY MACHINE DISINFECTANTK854011RENALFO HEMOFILTER CAVHDK844790RENAFLO HEMOCONCENTRATORK843963DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWDK844108RENAL SYSTEMS PERITONEAL ACCESS SYSTEM

View all 35 devices →

Related Devices (Code: FKQ)

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.

K052764DIACAP ULTRA DIALYSIS FLUID FILTERB. Braun Medizintechnologie GmbHK893612TWO TANK DISSOLUTION MODULENational Medical Care, Medical Products Div., Inc.K874084MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDMNational Medical Care, Medical Products Div., Inc.K873421KAWASUMI A.V. FISTULA SETKawasumi Laboratories Co., Ltd.K870889ACID FUCHSIN SOLUTIONSD.R.G. Scientific IndustriesK861730ACTRIL FOR KIDNEY MACHINE DISINFECTANTRenal Systems, Inc.

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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