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FDA 510(k)

TRAVENOL INFUSION CONTROLLER 2M8052

K-Number: K812510 · 1981-09-16

ApplicantTravenol Laboratories, S.A.
Decision Date1981-09-16
Product CodeLDR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TRAVENOL INFUSION CONTROLLER 2M8052 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 1981-09-16 under 510(k) number K812510. The device is classified under product code LDR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAVENOL INFUSION CONTROLLER 2M8052?

TRAVENOL INFUSION CONTROLLER 2M8052 is a medical device that received FDA 510(k) clearance on 1981-09-16. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K812510.

When did TRAVENOL INFUSION CONTROLLER 2M8052 receive FDA 510(k) clearance?

TRAVENOL INFUSION CONTROLLER 2M8052 received FDA 510(k) clearance on 1981-09-16, under 510(k) number K812510.

Who is the listed applicant for TRAVENOL INFUSION CONTROLLER 2M8052?

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 TRAVENOL INFUSION CONTROLLER 2M8052?

The FDA product code for TRAVENOL INFUSION CONTROLLER 2M8052 is LDR.

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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: LDR)

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.

K242693DEKA Infusion System, DEKA Administration SetDeka Research and Development CorporationK232316DEKA Infusion System, DEKA Administration SetDeka Research and DevelopmentK153760Volumetric Infusion ControllerDEKA Research & DevelopmentK963136PACER MODEL 100 INFUSION CONTROLLERHealth Watch, Inc.K971826ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500Alexander Mfg. Co.K971865ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3PAlexander Mfg. Co.

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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