OPT-SHIELD 空氣，仰臥；OPT-SHIELD，結石攝石術
K 號：K162562 · 2017-03-17
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器材摘要
OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY is the device name listed in this FDA 510(k) record. The listed applicant is Bcg Medical, LLC. It received FDA 510(k) clearance on 2017-03-17 under 510(k) number K162562. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY?
OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY is a medical device that received FDA 510(k) clearance on 2017-03-17. The listed applicant is Bcg Medical, LLC. The 510(k) number is K162562.
When did OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY receive FDA 510(k) clearance?
OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY received FDA 510(k) clearance on 2017-03-17, under 510(k) number K162562.
Who is the listed applicant for OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY?
The FDA 510(k) record lists Bcg Medical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY?
The FDA product code for OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY is DWJ.
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相關器械（代碼：DWJ）
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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