BeShape One Device
K-Number: K231628 · 2023-09-29
ApplicantBeshape Technologies , Ltd.
Decision Date2023-09-29
Product CodeOHV
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
BeShape One Device is a medical device manufactured by Beshape Technologies , Ltd.. It received FDA 510(k) clearance on 2023-09-29 under approval number K231628. The device is classified under product code OHV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BeShape One Device?
BeShape One Device is a medical device that received FDA 510(k) clearance on 2023-09-29. It is manufactured by Beshape Technologies , Ltd.. The 510(k) number is K231628.
When was BeShape One Device approved by the FDA?
BeShape One Device received FDA 510(k) clearance on 2023-09-29, under approval number K231628.
What company makes BeShape One Device?
BeShape One Device is manufactured by Beshape Technologies , Ltd..
What is the FDA product code for BeShape One Device?
The FDA product code for BeShape One Device is OHV.
Related Devices (Code: OHV)
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.