Deka Tiac II
K-Number: K211091 · 2021-10-15
ApplicantEl.En Electronic Engineering Spa
Decision Date2021-10-15
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Deka Tiac II is a medical device manufactured by El.En Electronic Engineering Spa. It received FDA 510(k) clearance on 2021-10-15 under approval number K211091. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Deka Tiac II?
Deka Tiac II is a medical device that received FDA 510(k) clearance on 2021-10-15. It is manufactured by El.En Electronic Engineering Spa. The 510(k) number is K211091.
When was Deka Tiac II approved by the FDA?
Deka Tiac II received FDA 510(k) clearance on 2021-10-15, under approval number K211091.
What company makes Deka Tiac II?
Deka Tiac II is manufactured by El.En Electronic Engineering Spa.
What is the FDA product code for Deka Tiac II?
The FDA product code for Deka Tiac II is PBX.
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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.