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FDA 510(k)

SolidAIRity III 氣道穩定系統

K 號：K190630 · 2019-10-09

申請人Securisyn Medical, LLC
決定日期2019-10-09
產品代碼BTR
諮詢委員會AN
決定相當於

器材摘要

SolidAIRity III Airway Stabilization System is the device name listed in this FDA 510(k) record. The listed applicant is Securisyn Medical, LLC. It received FDA 510(k) clearance on 2019-10-09 under 510(k) number K190630. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SolidAIRity III Airway Stabilization System?

SolidAIRity III Airway Stabilization System is a medical device that received FDA 510(k) clearance on 2019-10-09. The listed applicant is Securisyn Medical, LLC. The 510(k) number is K190630.

When did SolidAIRity III Airway Stabilization System receive FDA 510(k) clearance?

SolidAIRity III Airway Stabilization System received FDA 510(k) clearance on 2019-10-09, under 510(k) number K190630.

Who is the listed applicant for SolidAIRity III Airway Stabilization System?

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

What is the FDA product code for SolidAIRity III Airway Stabilization System?

The FDA product code for SolidAIRity III Airway Stabilization System is BTR.

相關臨床試驗

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