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FDA 510(k)

REFORMAT GATEWAY

K-Number: K052284 · 2005-10-17

ApplicantInfinitt Co., Ltd.
Decision Date2005-10-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

REFORMAT GATEWAY is the device name listed in this FDA 510(k) record. The listed applicant is Infinitt Co., Ltd.. It received FDA 510(k) clearance on 2005-10-17 under 510(k) number K052284. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REFORMAT GATEWAY?

REFORMAT GATEWAY is a medical device that received FDA 510(k) clearance on 2005-10-17. The listed applicant is Infinitt Co., Ltd.. The 510(k) number is K052284.

When did REFORMAT GATEWAY receive FDA 510(k) clearance?

REFORMAT GATEWAY received FDA 510(k) clearance on 2005-10-17, under 510(k) number K052284.

Who is the listed applicant for REFORMAT GATEWAY?

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

What is the FDA product code for REFORMAT GATEWAY?

The FDA product code for REFORMAT GATEWAY is LLZ.

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Other records listing Infinitt Co., 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.

K163290INFINITT ULiteK111660XELIS CARDIACK111613XELIS FUSIONK103130XELIS 3DK102684XELIS DENTALK082990INFINITT XELIS

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Related Devices (Code: LLZ)

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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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