LSFG-NAVI
K号: K153239 · 2016-05-12
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决定日期2016-05-12
产品代码HKI
咨询委员会OP
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决定实质等同
器械摘要
LSFG-NAVI is the device name listed in this FDA 510(k) record. The listed applicant is Softcare Co., Ltd.. It received FDA 510(k) clearance on 2016-05-12 under 510(k) number K153239. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the LSFG-NAVI?
LSFG-NAVI is a medical device that received FDA 510(k) clearance on 2016-05-12. The listed applicant is Softcare Co., Ltd.. The 510(k) number is K153239.
When did LSFG-NAVI receive FDA 510(k) clearance?
LSFG-NAVI received FDA 510(k) clearance on 2016-05-12, under 510(k) number K153239.
Who is the listed applicant for LSFG-NAVI?
The FDA 510(k) record lists Softcare Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LSFG-NAVI?
The FDA product code for LSFG-NAVI is HKI.
相关器械（代码：HKI）
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官方来源
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