VYBE RF Electrosurgical System
K-Number: K230968 · 2023-07-06
ApplicantShenB Co., Ltd.
Decision Date2023-07-06
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
VYBE RF Electrosurgical System is a medical device manufactured by ShenB Co., Ltd.. It received FDA 510(k) clearance on 2023-07-06 under approval number K230968. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VYBE RF Electrosurgical System?
VYBE RF Electrosurgical System is a medical device that received FDA 510(k) clearance on 2023-07-06. It is manufactured by ShenB Co., Ltd.. The 510(k) number is K230968.
When was VYBE RF Electrosurgical System approved by the FDA?
VYBE RF Electrosurgical System received FDA 510(k) clearance on 2023-07-06, under approval number K230968.
What company makes VYBE RF Electrosurgical System?
VYBE RF Electrosurgical System is manufactured by ShenB Co., Ltd..
What is the FDA product code for VYBE RF Electrosurgical System?
The FDA product code for VYBE RF Electrosurgical System is GEI.
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Official Source
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