FDA 510(k)

Infinity™光學斷層掃描系統及PASS光學斷層掃描脊柱系統

K 號：K220810 · 2022-04-19

決定日期2022-04-19

產品代碼NKG

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決定相當於

器材摘要

Infinity™ OCT System and PASS OCT Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea International. It received FDA 510(k) clearance on 2022-04-19 under 510(k) number K220810. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Infinity™ OCT System and PASS OCT Spinal System?

Infinity™ OCT System and PASS OCT Spinal System is a medical device that received FDA 510(k) clearance on 2022-04-19. The listed applicant is Medicrea International. The 510(k) number is K220810.

When did Infinity™ OCT System and PASS OCT Spinal System receive FDA 510(k) clearance?

Infinity™ OCT System and PASS OCT Spinal System received FDA 510(k) clearance on 2022-04-19, under 510(k) number K220810.

Who is the listed applicant for Infinity™ OCT System and PASS OCT Spinal System?

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

What is the FDA product code for Infinity™ OCT System and PASS OCT Spinal System?

The FDA product code for Infinity™ OCT System and PASS OCT Spinal System is NKG.

其他以 Medicrea International 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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相關器械（代碼：NKG）

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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官方來源

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