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FDA 510(k)

ZYNO MEDICAL ADMINISTRATION SET

K-Number: K120685 · 2012-09-07

ApplicantZyno Medical, LLC
Decision Date2012-09-07
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ZYNO MEDICAL ADMINISTRATION SET is the device name listed in this FDA 510(k) record. The listed applicant is Zyno Medical, LLC. It received FDA 510(k) clearance on 2012-09-07 under 510(k) number K120685. 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 ZYNO MEDICAL ADMINISTRATION SET?

ZYNO MEDICAL ADMINISTRATION SET is a medical device that received FDA 510(k) clearance on 2012-09-07. The listed applicant is Zyno Medical, LLC. The 510(k) number is K120685.

When did ZYNO MEDICAL ADMINISTRATION SET receive FDA 510(k) clearance?

ZYNO MEDICAL ADMINISTRATION SET received FDA 510(k) clearance on 2012-09-07, under 510(k) number K120685.

Who is the listed applicant for ZYNO MEDICAL ADMINISTRATION SET?

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

What is the FDA product code for ZYNO MEDICAL ADMINISTRATION SET?

The FDA product code for ZYNO MEDICAL ADMINISTRATION SET is FPA.

Related Clinical Trials

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Other records listing Zyno Medical, LLC 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.

K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)K130690Z-800 INFUSION SYSTEMK100705ZYNO Z-800 INFUSION SYSTEM MODEL Z-800K071545Z-800 VOLUMETRIC INFUSION PUMP

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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