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FDA 510(k)

FLO-GARD 8000 INFUSION PUMP SYSTEM

K-Number: K813403 · 1981-12-31

ApplicantTravenol Laboratories, S.A.
Decision Date1981-12-31
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FLO-GARD 8000 INFUSION PUMP SYSTEM 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 1981-12-31 under 510(k) number K813403. 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 8000 INFUSION PUMP SYSTEM?

FLO-GARD 8000 INFUSION PUMP SYSTEM is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K813403.

When did FLO-GARD 8000 INFUSION PUMP SYSTEM receive FDA 510(k) clearance?

FLO-GARD 8000 INFUSION PUMP SYSTEM received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813403.

Who is the listed applicant for FLO-GARD 8000 INFUSION PUMP SYSTEM?

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 8000 INFUSION PUMP SYSTEM?

The FDA product code for FLO-GARD 8000 INFUSION PUMP SYSTEM is FRN.

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Other records listing Travenol Laboratories, S.A. as applicant

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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)

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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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