FDA 510(k)

CRC PC 智能隔間 K1

K 號：K192199 · 2019-09-12

決定日期2019-09-12

產品代碼KPT

諮詢委員會RA

決定相當於

器材摘要

CRC PC Smart Chamber K1 is the device name listed in this FDA 510(k) record. The listed applicant is Capintec, Inc.. It received FDA 510(k) clearance on 2019-09-12 under 510(k) number K192199. The device is classified under product code KPT. It was reviewed by the RA advisory panel. Product code KPT falls under the category of In Vitro Diagnostics, which includes laboratory reagents and diagnostic test kits. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the CRC PC Smart Chamber K1?

CRC PC Smart Chamber K1 is a medical device that received FDA 510(k) clearance on 2019-09-12. The listed applicant is Capintec, Inc.. The 510(k) number is K192199.

When did CRC PC Smart Chamber K1 receive FDA 510(k) clearance?

CRC PC Smart Chamber K1 received FDA 510(k) clearance on 2019-09-12, under 510(k) number K192199.

Who is the listed applicant for CRC PC Smart Chamber K1?

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

What is the FDA product code for CRC PC Smart Chamber K1?

The FDA product code for CRC PC Smart Chamber K1 is KPT. This falls under the In Vitro Diagnostics category.

其他以 Capintec, 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。

K162394CRC-77tHR

相關器械（代碼：KPT）

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。

K162394CRC-77tHRCapintec, Inc.

官方來源

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