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FDA 510(k)

ALLON 2001 MODIFIED

K-Number: K003349 · 2000-11-13

ApplicantMtre Advanced Technology , Ltd.
Decision Date2000-11-13
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ALLON 2001 MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Mtre Advanced Technology , Ltd.. It received FDA 510(k) clearance on 2000-11-13 under 510(k) number K003349. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALLON 2001 MODIFIED?

ALLON 2001 MODIFIED is a medical device that received FDA 510(k) clearance on 2000-11-13. The listed applicant is Mtre Advanced Technology , Ltd.. The 510(k) number is K003349.

When did ALLON 2001 MODIFIED receive FDA 510(k) clearance?

ALLON 2001 MODIFIED received FDA 510(k) clearance on 2000-11-13, under 510(k) number K003349.

Who is the listed applicant for ALLON 2001 MODIFIED?

The FDA 510(k) record lists Mtre Advanced Technology , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALLON 2001 MODIFIED?

The FDA product code for ALLON 2001 MODIFIED is DWJ.

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 Mtre Advanced Technology , Ltd. 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.

K102112CRITICOOL PROK083662CRITICOOLK024128ALLON 2001 VERSION 5K001546ALLON 2001K992386ALLON 2000

Related Devices (Code: DWJ)

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.

K262089Disposable Warming BlanketHangzhou Tappa Medical Technology Co., Ltd.K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC LifeK260278ThermAffyx(TM) Patient Safety SystemStihler Electronic GmbHK260903Hot Pink Pad Warming SystemXodus Medical, Inc.K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd.K251974Arctic Sun Temperature Management System (Model 5000)Medivance, 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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