FDA 510(k)

卡德韋爾放大掃描器

K 號：K161027 · 2016-11-08

決定日期2016-11-08

產品代碼OMA

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Cadwell AmpliScan is the device name listed in this FDA 510(k) record. The listed applicant is Cadwell Industries, Inc.. It received FDA 510(k) clearance on 2016-11-08 under 510(k) number K161027. The device is classified under product code OMA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cadwell AmpliScan?

Cadwell AmpliScan is a medical device that received FDA 510(k) clearance on 2016-11-08. The listed applicant is Cadwell Industries, Inc.. The 510(k) number is K161027.

When did Cadwell AmpliScan receive FDA 510(k) clearance?

Cadwell AmpliScan received FDA 510(k) clearance on 2016-11-08, under 510(k) number K161027.

Who is the listed applicant for Cadwell AmpliScan?

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

What is the FDA product code for Cadwell AmpliScan?

The FDA product code for Cadwell AmpliScan is OMA.

其他以 Cadwell Industries, Inc. 為申請人之記錄

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相關器械（代碼：OMA）

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