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FDA 510(k)

FLO-GARD 8100 INFUSION PUMP

K-Number: K833958 · 1983-12-29

ApplicantTravenol Laboratories, S.A.
Decision Date1983-12-29
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FLO-GARD 8100 INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Travenol Laboratories, S.A.. It received FDA 510(k) clearance on 1983-12-29 under 510(k) number K833958. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLO-GARD 8100 INFUSION PUMP?

FLO-GARD 8100 INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1983-12-29. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K833958.

When did FLO-GARD 8100 INFUSION PUMP receive FDA 510(k) clearance?

FLO-GARD 8100 INFUSION PUMP received FDA 510(k) clearance on 1983-12-29, under 510(k) number K833958.

Who is the listed applicant for FLO-GARD 8100 INFUSION PUMP?

The FDA 510(k) record lists Travenol Laboratories, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLO-GARD 8100 INFUSION PUMP?

The FDA product code for FLO-GARD 8100 INFUSION PUMP is FRN.

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Other records listing Travenol Laboratories, S.A. 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.

K874181BAXTER BEDSIDE SYSTEMK873894CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITEK873873RESUBMITTED MICRON TRANSFUSION FILTERK873984AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)K872364HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309K872652UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM

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Related Devices (Code: FRN)

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.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, 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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