細菌掃描216Dx系統
K 號：K172412 · 2018-05-01
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器材摘要
BacterioScan 216Dx System is the device name listed in this FDA 510(k) record. The listed applicant is Bacterioscan, Inc.. It received FDA 510(k) clearance on 2018-05-01 under 510(k) number K172412. The device is classified under product code QBQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the BacterioScan 216Dx System?
BacterioScan 216Dx System is a medical device that received FDA 510(k) clearance on 2018-05-01. The listed applicant is Bacterioscan, Inc.. The 510(k) number is K172412.
When did BacterioScan 216Dx System receive FDA 510(k) clearance?
BacterioScan 216Dx System received FDA 510(k) clearance on 2018-05-01, under 510(k) number K172412.
Who is the listed applicant for BacterioScan 216Dx System?
The FDA 510(k) record lists Bacterioscan, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BacterioScan 216Dx System?
The FDA product code for BacterioScan 216Dx System is QBQ.
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官方來源
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