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FDA 510(k)

MANZI CLEANER SYSTEM

K-Number: K043314 · 2005-06-20

ApplicantLangford IC Systems, Inc.
Decision Date2005-06-20
Product CodeNVE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MANZI CLEANER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Langford IC Systems, Inc.. It received FDA 510(k) clearance on 2005-06-20 under 510(k) number K043314. The device is classified under product code NVE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANZI CLEANER SYSTEM?

MANZI CLEANER SYSTEM is a medical device that received FDA 510(k) clearance on 2005-06-20. The listed applicant is Langford IC Systems, Inc.. The 510(k) number is K043314.

When did MANZI CLEANER SYSTEM receive FDA 510(k) clearance?

MANZI CLEANER SYSTEM received FDA 510(k) clearance on 2005-06-20, under 510(k) number K043314.

Who is the listed applicant for MANZI CLEANER SYSTEM?

The FDA 510(k) record lists Langford IC Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MANZI CLEANER SYSTEM?

The FDA product code for MANZI CLEANER SYSTEM is NVE.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Langford IC Systems, Inc. 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.

K101158LIC INSTRUMENT PROCESSING SYSTEMK060458MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR

Related Devices (Code: NVE)

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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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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