FDA 510(k)

規範用藥品名稱：SPEC 模型 M13

K 號：K161395 · 2016-07-06

申請人Source Production and Equipment Co., Inc.

決定日期2016-07-06

產品代碼KXK

諮詢委員會RA

決定相當於

器材摘要

SPEC Model M13 is the device name listed in this FDA 510(k) record. The listed applicant is Source Production and Equipment Co., Inc.. It received FDA 510(k) clearance on 2016-07-06 under 510(k) number K161395. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SPEC Model M13?

SPEC Model M13 is a medical device that received FDA 510(k) clearance on 2016-07-06. The listed applicant is Source Production and Equipment Co., Inc.. The 510(k) number is K161395.

When did SPEC Model M13 receive FDA 510(k) clearance?

SPEC Model M13 received FDA 510(k) clearance on 2016-07-06, under 510(k) number K161395.

Who is the listed applicant for SPEC Model M13?

The FDA 510(k) record lists Source Production and Equipment Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPEC Model M13?

The FDA product code for SPEC Model M13 is KXK.

其他以 Source Production and Equipment Co., Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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