Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is El.En Electronic Engineering Spa. It received FDA 510(k) clearance on 2021-10-15 under 510(k) 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. The listed applicant is El.En Electronic Engineering Spa. The 510(k) number is K211091.

When did Deka Tiac II receive FDA 510(k) clearance?

Deka Tiac II received FDA 510(k) clearance on 2021-10-15, under 510(k) number K211091.

Who is the listed applicant for Deka Tiac II?

The FDA 510(k) record lists El.En Electronic Engineering Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Deka Tiac II?

The FDA product code for Deka Tiac II is PBX.

Other records listing El.En Electronic Engineering Spa as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222221DEKA HELIXK213658DEKA SMARTPERIOK212270DEKA LipoAIK211362SCAR 3K203396DEKA SMARTPERIOK211821DEKA Motus AZ

View all 17 devices →

Related Devices (Code: PBX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.K260647SPECCHIOEl.En S.P.A.K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.K252888NeoSculpt PlusS&M Medical Co., Ltd.K250734OptiLUV DevicePollogen, Ltd.K250916WinForth (LM-E470KA)Shenzhen Leaflife Technology Co., Ltd.

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.

↑