Lancet
K-Number: K221839 · 2022-09-19
ApplicantHebei Xinle Sci&Tech Co., Ltd.
Decision Date2022-09-19
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Lancet is a medical device manufactured by Hebei Xinle Sci&Tech Co., Ltd.. It received FDA 510(k) clearance on 2022-09-19 under approval number K221839. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Lancet?
Lancet is a medical device that received FDA 510(k) clearance on 2022-09-19. It is manufactured by Hebei Xinle Sci&Tech Co., Ltd.. The 510(k) number is K221839.
When was Lancet approved by the FDA?
Lancet received FDA 510(k) clearance on 2022-09-19, under approval number K221839.
What company makes Lancet?
Lancet is manufactured by Hebei Xinle Sci&Tech Co., Ltd..
What is the FDA product code for Lancet?
The FDA product code for Lancet is FMK.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.