FDA 510(k)

ProxiDiagnost N90 / 精準CRF (706110, 706400)

K 號：K233945 · 2024-01-11

決定日期2024-01-11

產品代碼JAA

諮詢委員會RA

決定相當於

器材摘要

ProxiDiagnost N90 / Precision CRF (706110, 706400) is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Dmc GmbH. It received FDA 510(k) clearance on 2024-01-11 under 510(k) number K233945. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ProxiDiagnost N90 / Precision CRF (706110, 706400)?

ProxiDiagnost N90 / Precision CRF (706110, 706400) is a medical device that received FDA 510(k) clearance on 2024-01-11. The listed applicant is Philips Medical Systems Dmc GmbH. The 510(k) number is K233945.

When did ProxiDiagnost N90 / Precision CRF (706110, 706400) receive FDA 510(k) clearance?

ProxiDiagnost N90 / Precision CRF (706110, 706400) received FDA 510(k) clearance on 2024-01-11, under 510(k) number K233945.

Who is the listed applicant for ProxiDiagnost N90 / Precision CRF (706110, 706400)?

The FDA 510(k) record lists Philips Medical Systems Dmc GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ProxiDiagnost N90 / Precision CRF (706110, 706400)?

The FDA product code for ProxiDiagnost N90 / Precision CRF (706110, 706400) is JAA.

其他以 Philips Medical Systems Dmc GmbH 為申請人之記錄

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相關器械（代碼：JAA）

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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