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FDA 510(k)

MX4000

K-Number: K943794 · 1994-12-14

ApplicantBfi- Medical Waste Systems
Decision Date1994-12-14
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MX4000 is the device name listed in this FDA 510(k) record. The listed applicant is Bfi- Medical Waste Systems. It received FDA 510(k) clearance on 1994-12-14 under 510(k) number K943794. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MX4000?

MX4000 is a medical device that received FDA 510(k) clearance on 1994-12-14. The listed applicant is Bfi- Medical Waste Systems. The 510(k) number is K943794.

When did MX4000 receive FDA 510(k) clearance?

MX4000 received FDA 510(k) clearance on 1994-12-14, under 510(k) number K943794.

Who is the listed applicant for MX4000?

The FDA 510(k) record lists Bfi- Medical Waste Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MX4000?

The FDA product code for MX4000 is FMI.

Other records listing Bfi- Medical Waste Systems 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.

K981184SHARPTRACK REUSABLE SHARPS CONTAINERK943771MEDX REUSABLE SHARPS CONTAINERK923356MEDX ROTATIONAL GANTRY SYSTEMK843582MULTI-FORMAT FILM CAMERAK827761MED-X MODEL 301 X-RAY FILTER

Related Devices (Code: FMI)

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.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

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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