SUITESTENSA
K-Number: K163668 · 2017-06-23
ApplicantEbit Srl
Decision Date2017-06-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SUITESTENSA is a medical device manufactured by Ebit Srl. It received FDA 510(k) clearance on 2017-06-23 under approval number K163668. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SUITESTENSA?
SUITESTENSA is a medical device that received FDA 510(k) clearance on 2017-06-23. It is manufactured by Ebit Srl. The 510(k) number is K163668.
When was SUITESTENSA approved by the FDA?
SUITESTENSA received FDA 510(k) clearance on 2017-06-23, under approval number K163668.
What company makes SUITESTENSA?
SUITESTENSA is manufactured by Ebit Srl.
What is the FDA product code for SUITESTENSA?
The FDA product code for SUITESTENSA is LLZ.
Related Devices (Code: LLZ)
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.