FDA 510(k)

Cadwell Bolt Software

K号: K190760 · 2019-11-23

决定日期2019-11-23

产品代码OLT

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决定实质等同

器械摘要

Cadwell Bolt Software 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 2019-11-23 under 510(k) number K190760. The device is classified under product code OLT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cadwell Bolt Software?

Cadwell Bolt Software is a medical device that received FDA 510(k) clearance on 2019-11-23. The listed applicant is Cadwell Industries, Inc.. The 510(k) number is K190760.

When did Cadwell Bolt Software receive FDA 510(k) clearance?

Cadwell Bolt Software received FDA 510(k) clearance on 2019-11-23, under 510(k) number K190760.

Who is the listed applicant for Cadwell Bolt Software?

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 Bolt Software?

The FDA product code for Cadwell Bolt Software is OLT.

列明Cadwell Industries, Inc.为申报人的其他记录

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