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FDA 510(k)

Z-800 VOLUMETRIC INFUSION PUMP

K-Number: K071545 · 2007-10-31

ApplicantZyno Medical, LLC
Decision Date2007-10-31
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Z-800 VOLUMETRIC INFUSION PUMP 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 2007-10-31 under 510(k) number K071545. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Z-800 VOLUMETRIC INFUSION PUMP?

Z-800 VOLUMETRIC INFUSION PUMP is a medical device that received FDA 510(k) clearance on 2007-10-31. The listed applicant is Zyno Medical, LLC. The 510(k) number is K071545.

When did Z-800 VOLUMETRIC INFUSION PUMP receive FDA 510(k) clearance?

Z-800 VOLUMETRIC INFUSION PUMP received FDA 510(k) clearance on 2007-10-31, under 510(k) number K071545.

Who is the listed applicant for Z-800 VOLUMETRIC INFUSION PUMP?

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 Z-800 VOLUMETRIC INFUSION PUMP?

The FDA product code for Z-800 VOLUMETRIC INFUSION PUMP is FRN.

Related Clinical Trials

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.

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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 SYSTEMK120685ZYNO MEDICAL ADMINISTRATION SETK100705ZYNO Z-800 INFUSION SYSTEM MODEL Z-800

Related Devices (Code: FRN)

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.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.

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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