BioSphere Flex
K-Number: K173424 · 2018-09-12
ApplicantSynergy Biomedical
Decision Date2018-09-12
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
BioSphere Flex is a medical device manufactured by Synergy Biomedical. It received FDA 510(k) clearance on 2018-09-12 under approval number K173424. 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 BioSphere Flex?
BioSphere Flex is a medical device that received FDA 510(k) clearance on 2018-09-12. It is manufactured by Synergy Biomedical. The 510(k) number is K173424.
When was BioSphere Flex approved by the FDA?
BioSphere Flex received FDA 510(k) clearance on 2018-09-12, under approval number K173424.
What company makes BioSphere Flex?
BioSphere Flex is manufactured by Synergy Biomedical.
What is the FDA product code for BioSphere Flex?
The FDA product code for BioSphere Flex is MQV.
Other Devices by Synergy Biomedical
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.