Piezon Built-in Kit, Piezon Built-in Kit LED
K-Number: K191079 · 2019-08-16
ApplicantE.M.S Electro Medical Systems S.A
Decision Date2019-08-16
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Piezon Built-in Kit, Piezon Built-in Kit LED is a medical device manufactured by E.M.S Electro Medical Systems S.A. It received FDA 510(k) clearance on 2019-08-16 under approval number K191079. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Piezon Built-in Kit, Piezon Built-in Kit LED?
Piezon Built-in Kit, Piezon Built-in Kit LED is a medical device that received FDA 510(k) clearance on 2019-08-16. It is manufactured by E.M.S Electro Medical Systems S.A. The 510(k) number is K191079.
When was Piezon Built-in Kit, Piezon Built-in Kit LED approved by the FDA?
Piezon Built-in Kit, Piezon Built-in Kit LED received FDA 510(k) clearance on 2019-08-16, under approval number K191079.
What company makes Piezon Built-in Kit, Piezon Built-in Kit LED?
Piezon Built-in Kit, Piezon Built-in Kit LED is manufactured by E.M.S Electro Medical Systems S.A.
What is the FDA product code for Piezon Built-in Kit, Piezon Built-in Kit LED?
The FDA product code for Piezon Built-in Kit, Piezon Built-in Kit LED is ELC.
Other Devices by E.M.S Electro Medical Systems S.A
Related Devices (Code: ELC)
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.