SX-One 微針
K 號：K192873 · 2019-12-20
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器材摘要
SX-One MicroKnife is the device name listed in this FDA 510(k) record. The listed applicant is Sonex Health, Inc.. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K192873. The device is classified under product code LXH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SX-One MicroKnife?
SX-One MicroKnife is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Sonex Health, Inc.. The 510(k) number is K192873.
When did SX-One MicroKnife receive FDA 510(k) clearance?
SX-One MicroKnife received FDA 510(k) clearance on 2019-12-20, under 510(k) number K192873.
Who is the listed applicant for SX-One MicroKnife?
The FDA 510(k) record lists Sonex Health, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SX-One MicroKnife?
The FDA product code for SX-One MicroKnife is LXH.
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官方來源
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