IVD膽囊PSP；abioSCOPE
K 號：K240041 · 2024-09-25
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器材摘要
IVD CAPSULE PSP; abioSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Abionic SA. It received FDA 510(k) clearance on 2024-09-25 under 510(k) number K240041. The device is classified under product code SCX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the IVD CAPSULE PSP; abioSCOPE?
IVD CAPSULE PSP; abioSCOPE is a medical device that received FDA 510(k) clearance on 2024-09-25. The listed applicant is Abionic SA. The 510(k) number is K240041.
When did IVD CAPSULE PSP; abioSCOPE receive FDA 510(k) clearance?
IVD CAPSULE PSP; abioSCOPE received FDA 510(k) clearance on 2024-09-25, under 510(k) number K240041.
Who is the listed applicant for IVD CAPSULE PSP; abioSCOPE?
The FDA 510(k) record lists Abionic SA as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for IVD CAPSULE PSP; abioSCOPE?
The FDA product code for IVD CAPSULE PSP; abioSCOPE is SCX.
相關臨床試驗
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官方來源
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