FDA 510(k)

Cadwell AmpliScan

K号: K161027 · 2016-11-08

决定日期2016-11-08

产品代码OMA

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决定实质等同

器械摘要

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.

常见问题

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.

列明Cadwell Industries, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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