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FDA 510(k)

RS-7800 MINIPUMP

K-Number: K771705 · 1977-10-04

ApplicantRenal Systems, Inc.
Decision Date1977-10-04
Product CodeFIR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RS-7800 MINIPUMP 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 1977-10-04 under 510(k) number K771705. The device is classified under product code FIR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RS-7800 MINIPUMP?

RS-7800 MINIPUMP is a medical device that received FDA 510(k) clearance on 1977-10-04. The listed applicant is Renal Systems, Inc.. The 510(k) number is K771705.

When did RS-7800 MINIPUMP receive FDA 510(k) clearance?

RS-7800 MINIPUMP received FDA 510(k) clearance on 1977-10-04, under 510(k) number K771705.

Who is the listed applicant for RS-7800 MINIPUMP?

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 RS-7800 MINIPUMP?

The FDA product code for RS-7800 MINIPUMP is FIR.

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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

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Related Devices (Code: FIR)

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.

K961137ATI PLASMA PUMP (PP-04)Apheresis Technologies, Inc.K831953INFUSION PUMPCryosan, Inc.K830818ASAHI BLOOD/PLASMA PUMP #ABP-01A &Parker Hannifin Corp.K821139SPS-SINGLE PATIENT SYSTEMExtracorporeal Medical Specialities, Inc.K780410BLOOD PUMP-MODE S10K3M Health Care, SarnsK761050HEPARIN PUMPDws, 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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