si-Mochi
K-Number: K202639 · 2021-04-21
ApplicantBiostone, Ltd.
Decision Date2021-04-21
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
si-Mochi is a medical device manufactured by Biostone, Ltd.. It received FDA 510(k) clearance on 2021-04-21 under approval number K202639. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the si-Mochi?
si-Mochi is a medical device that received FDA 510(k) clearance on 2021-04-21. It is manufactured by Biostone, Ltd.. The 510(k) number is K202639.
When was si-Mochi approved by the FDA?
si-Mochi received FDA 510(k) clearance on 2021-04-21, under approval number K202639.
What company makes si-Mochi?
si-Mochi is manufactured by Biostone, Ltd..
What is the FDA product code for si-Mochi?
The FDA product code for si-Mochi is MQV.
Related Devices (Code: MQV)
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.