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FDA 510(k)

MZ1000

K-Number: K132413 · 2013-08-29

ApplicantCare Fusion
Decision Date2013-08-29
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MZ1000 is the device name listed in this FDA 510(k) record. The listed applicant is Care Fusion. It received FDA 510(k) clearance on 2013-08-29 under 510(k) number K132413. 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 MZ1000?

MZ1000 is a medical device that received FDA 510(k) clearance on 2013-08-29. The listed applicant is Care Fusion. The 510(k) number is K132413.

When did MZ1000 receive FDA 510(k) clearance?

MZ1000 received FDA 510(k) clearance on 2013-08-29, under 510(k) number K132413.

Who is the listed applicant for MZ1000?

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

What is the FDA product code for MZ1000?

The FDA product code for MZ1000 is FPA.

Other records listing Care Fusion 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.

K233021BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access DeviceK231888BD Texium™ Needle-Free SyringeK221319BD Alaris™ Pump Epidural Infusion SetK221327BD Alaris™ Pump Infusion SetsK223101BD Secondary Infusion SetK223088BD SmartSite™ Needle-Free Connector

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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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