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FDA 510(k)

UC-CARE POSITIONING SYSTEM

K-Number: K082919 · 2008-10-27

ApplicantUc-Care Medical Systems, Ltd.
Decision Date2008-10-27
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UC-CARE POSITIONING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Uc-Care Medical Systems, Ltd.. It received FDA 510(k) clearance on 2008-10-27 under 510(k) number K082919. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UC-CARE POSITIONING SYSTEM?

UC-CARE POSITIONING SYSTEM is a medical device that received FDA 510(k) clearance on 2008-10-27. The listed applicant is Uc-Care Medical Systems, Ltd.. The 510(k) number is K082919.

When did UC-CARE POSITIONING SYSTEM receive FDA 510(k) clearance?

UC-CARE POSITIONING SYSTEM received FDA 510(k) clearance on 2008-10-27, under 510(k) number K082919.

Who is the listed applicant for UC-CARE POSITIONING SYSTEM?

The FDA 510(k) record lists Uc-Care Medical Systems, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UC-CARE POSITIONING SYSTEM?

The FDA product code for UC-CARE POSITIONING SYSTEM is EZL.

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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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