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FDA 510(k)

DEKA SMARTPERIO

K-Number: K203396 · 2021-08-23

ApplicantEl.En Electronic Engineering Spa
Decision Date2021-08-23
Product CodeNVK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEKA SMARTPERIO 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 2021-08-23 under 510(k) number K203396. The device is classified under product code NVK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEKA SMARTPERIO?

DEKA SMARTPERIO is a medical device that received FDA 510(k) clearance on 2021-08-23. The listed applicant is El.En Electronic Engineering Spa. The 510(k) number is K203396.

When did DEKA SMARTPERIO receive FDA 510(k) clearance?

DEKA SMARTPERIO received FDA 510(k) clearance on 2021-08-23, under 510(k) number K203396.

Who is the listed applicant for DEKA SMARTPERIO?

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 SMARTPERIO?

The FDA product code for DEKA SMARTPERIO is NVK.

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.

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Related Devices (Code: NVK)

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.

K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)Shenzhen Soga Technology Co., Ltd.K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLCK250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.K230047Medical Diode Laser SystemsGigaalaser Company , Ltd.K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.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.

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