FDA 510(k)

Synaptive ImageDrive Pro

K 號：K153284 · 2016-03-29

決定日期2016-03-29

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Synaptive ImageDrive Pro is the device name listed in this FDA 510(k) record. The listed applicant is Synaptive Medical, Inc.. It received FDA 510(k) clearance on 2016-03-29 under 510(k) number K153284. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Synaptive ImageDrive Pro?

Synaptive ImageDrive Pro is a medical device that received FDA 510(k) clearance on 2016-03-29. The listed applicant is Synaptive Medical, Inc.. The 510(k) number is K153284.

When did Synaptive ImageDrive Pro receive FDA 510(k) clearance?

Synaptive ImageDrive Pro received FDA 510(k) clearance on 2016-03-29, under 510(k) number K153284.

Who is the listed applicant for Synaptive ImageDrive Pro?

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

What is the FDA product code for Synaptive ImageDrive Pro?

The FDA product code for Synaptive ImageDrive Pro is LLZ.

其他以 Synaptive Medical, Inc. 為申請人之記錄

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相關器械（代碼：LLZ）

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