DRAGON X SPSL4HC, DRAGON X SPSL8HC
K-Number: K173299 · 2018-01-26
ApplicantSedecal., Sa.
Decision Date2018-01-26
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
DRAGON X SPSL4HC, DRAGON X SPSL8HC is a medical device manufactured by Sedecal., Sa.. It received FDA 510(k) clearance on 2018-01-26 under approval number K173299. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DRAGON X SPSL4HC, DRAGON X SPSL8HC?
DRAGON X SPSL4HC, DRAGON X SPSL8HC is a medical device that received FDA 510(k) clearance on 2018-01-26. It is manufactured by Sedecal., Sa.. The 510(k) number is K173299.
When was DRAGON X SPSL4HC, DRAGON X SPSL8HC approved by the FDA?
DRAGON X SPSL4HC, DRAGON X SPSL8HC received FDA 510(k) clearance on 2018-01-26, under approval number K173299.
What company makes DRAGON X SPSL4HC, DRAGON X SPSL8HC?
DRAGON X SPSL4HC, DRAGON X SPSL8HC is manufactured by Sedecal., Sa..
What is the FDA product code for DRAGON X SPSL4HC, DRAGON X SPSL8HC?
The FDA product code for DRAGON X SPSL4HC, DRAGON X SPSL8HC is IZL.
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Official Source
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