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FDA 510(k)

ZYNO Z-800 INFUSION SYSTEM MODEL Z-800

K-Number: K100705 · 2010-07-08

ApplicantZyno Medical, LLC
Decision Date2010-07-08
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 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 2010-07-08 under 510(k) number K100705. 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 ZYNO Z-800 INFUSION SYSTEM MODEL Z-800?

ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 is a medical device that received FDA 510(k) clearance on 2010-07-08. The listed applicant is Zyno Medical, LLC. The 510(k) number is K100705.

When did ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 receive FDA 510(k) clearance?

ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 received FDA 510(k) clearance on 2010-07-08, under 510(k) number K100705.

Who is the listed applicant for ZYNO Z-800 INFUSION SYSTEM MODEL Z-800?

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 Z-800 INFUSION SYSTEM MODEL Z-800?

The FDA product code for ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 is FRN.

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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 SETK071545Z-800 VOLUMETRIC INFUSION PUMP

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

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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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