FDA 510(k)

HAPI 密封

K 號：K162598 · 2017-05-23

決定日期2017-05-23

產品代碼EBC

諮詢委員會DE

決定相當於

器材摘要

HAPI Seal is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2017-05-23 under 510(k) number K162598. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HAPI Seal?

HAPI Seal is a medical device that received FDA 510(k) clearance on 2017-05-23. The listed applicant is Bisco, Inc.. The 510(k) number is K162598.

When did HAPI Seal receive FDA 510(k) clearance?

HAPI Seal received FDA 510(k) clearance on 2017-05-23, under 510(k) number K162598.

Who is the listed applicant for HAPI Seal?

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

What is the FDA product code for HAPI Seal?

The FDA product code for HAPI Seal is EBC.

其他以 Bisco, Inc. 為申請人之記錄

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