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FDA 510(k)

AMMI MAGNI-GUARD

K-Number: K961454 · 1996-07-25

ApplicantAmerican Medical Mfg., Inc.
Decision Date1996-07-25
Product CodeLYU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AMMI MAGNI-GUARD is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Mfg., Inc.. It received FDA 510(k) clearance on 1996-07-25 under 510(k) number K961454. The device is classified under product code LYU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMMI MAGNI-GUARD?

AMMI MAGNI-GUARD is a medical device that received FDA 510(k) clearance on 1996-07-25. The listed applicant is American Medical Mfg., Inc.. The 510(k) number is K961454.

When did AMMI MAGNI-GUARD receive FDA 510(k) clearance?

AMMI MAGNI-GUARD received FDA 510(k) clearance on 1996-07-25, under 510(k) number K961454.

Who is the listed applicant for AMMI MAGNI-GUARD?

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

What is the FDA product code for AMMI MAGNI-GUARD?

The FDA product code for AMMI MAGNI-GUARD is LYU.

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 American Medical Mfg., 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.

K982029SHARPS COLLECTION CONTAINER - SAF-T-SHELLK915066DISPOSABLE SKIN MARKERK915064DISPOSABLE CAUTERY ABRASIVE PADK915065I.V.IRRIGATION POLEK915068PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER

Related Devices (Code: LYU)

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.

K011755STRYKER T4 HYTREL (R) TOGASStryker Corp.K965237NURSES BOUFFANT CAPCopioumed Intl., Inc.K970988FAR-EAST BOUFFANT CAPSFar East Science & Technology Development Co., Ltd.K964364DISPOSABLE APRONInstrument Makar, Inc.K961791DEPUY DISPOSABLE FILTER/HOODDepuy, Inc.K945302SLOAN STA-DRI PANT PROTECTORSloan Corp.

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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