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FDA 510(k)

MediClear 預手術

K 號：K163556 · 2017-09-14

申請人Covalontechnologies, Inc.
決定日期2017-09-14
產品代碼KKX
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

MediClear PreOp is the device name listed in this FDA 510(k) record. The listed applicant is Covalontechnologies, Inc.. It received FDA 510(k) clearance on 2017-09-14 under 510(k) number K163556. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MediClear PreOp?

MediClear PreOp is a medical device that received FDA 510(k) clearance on 2017-09-14. The listed applicant is Covalontechnologies, Inc.. The 510(k) number is K163556.

When did MediClear PreOp receive FDA 510(k) clearance?

MediClear PreOp received FDA 510(k) clearance on 2017-09-14, under 510(k) number K163556.

Who is the listed applicant for MediClear PreOp?

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

What is the FDA product code for MediClear PreOp?

The FDA product code for MediClear PreOp is KKX.

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官方來源

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