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FDA 510(k)

ISOFLUX IXL FLOW REGULATOR

K-Number: K925733 · 1994-05-09

ApplicantFerguson Medical
Decision Date1994-05-09
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ISOFLUX IXL FLOW REGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Ferguson Medical. It received FDA 510(k) clearance on 1994-05-09 under 510(k) number K925733. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOFLUX IXL FLOW REGULATOR?

ISOFLUX IXL FLOW REGULATOR is a medical device that received FDA 510(k) clearance on 1994-05-09. The listed applicant is Ferguson Medical. The 510(k) number is K925733.

When did ISOFLUX IXL FLOW REGULATOR receive FDA 510(k) clearance?

ISOFLUX IXL FLOW REGULATOR received FDA 510(k) clearance on 1994-05-09, under 510(k) number K925733.

Who is the listed applicant for ISOFLUX IXL FLOW REGULATOR?

The FDA 510(k) record lists Ferguson Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISOFLUX IXL FLOW REGULATOR?

The FDA product code for ISOFLUX IXL FLOW REGULATOR is FPA.

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Other records listing Ferguson Medical as applicant

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Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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