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FDA 510(k)

INFINITT XELIS

K-Number: K082990 · 2008-11-20

ApplicantInfinitt Co., Ltd.
Decision Date2008-11-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INFINITT XELIS 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 2008-11-20 under 510(k) number K082990. 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 INFINITT XELIS?

INFINITT XELIS is a medical device that received FDA 510(k) clearance on 2008-11-20. The listed applicant is Infinitt Co., Ltd.. The 510(k) number is K082990.

When did INFINITT XELIS receive FDA 510(k) clearance?

INFINITT XELIS received FDA 510(k) clearance on 2008-11-20, under 510(k) number K082990.

Who is the listed applicant for INFINITT XELIS?

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 INFINITT XELIS?

The FDA product code for INFINITT XELIS 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 DENTALK082706INFINITT CARDIOLOGY PACS

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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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