FDA 510(k)

NormaTec PCD-T 和 PCD-B

K 號：K161346 · 2016-06-15

決定日期2016-06-15

產品代碼JOW

諮詢委員會履歷

決定相當於

器材摘要

NormaTec PCD-T and PCD-B is the device name listed in this FDA 510(k) record. The listed applicant is NormaTec Industries, LP. It received FDA 510(k) clearance on 2016-06-15 under 510(k) number K161346. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NormaTec PCD-T and PCD-B?

NormaTec PCD-T and PCD-B is a medical device that received FDA 510(k) clearance on 2016-06-15. The listed applicant is NormaTec Industries, LP. The 510(k) number is K161346.

When did NormaTec PCD-T and PCD-B receive FDA 510(k) clearance?

NormaTec PCD-T and PCD-B received FDA 510(k) clearance on 2016-06-15, under 510(k) number K161346.

Who is the listed applicant for NormaTec PCD-T and PCD-B?

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

What is the FDA product code for NormaTec PCD-T and PCD-B?

The FDA product code for NormaTec PCD-T and PCD-B is JOW.

其他以 NormaTec Industries, LP 為申請人之記錄

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相關器械（代碼：JOW）

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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