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FDA 510(k)

STA-SET I.V. FLOW REGULATOR

K-Number: K880006 · 1988-03-24

ApplicantControlled Flow , Ltd.
Decision Date1988-03-24
Product CodeLDR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STA-SET I.V. FLOW REGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Controlled Flow , Ltd.. It received FDA 510(k) clearance on 1988-03-24 under 510(k) number K880006. 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 STA-SET I.V. FLOW REGULATOR?

STA-SET I.V. FLOW REGULATOR is a medical device that received FDA 510(k) clearance on 1988-03-24. The listed applicant is Controlled Flow , Ltd.. The 510(k) number is K880006.

When did STA-SET I.V. FLOW REGULATOR receive FDA 510(k) clearance?

STA-SET I.V. FLOW REGULATOR received FDA 510(k) clearance on 1988-03-24, under 510(k) number K880006.

Who is the listed applicant for STA-SET I.V. FLOW REGULATOR?

The FDA 510(k) record lists Controlled Flow , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STA-SET I.V. FLOW REGULATOR?

The FDA product code for STA-SET I.V. FLOW REGULATOR is LDR.

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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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