FDA 510(k)

DEKA SMARTXIDE 가족(스마트시드 터치, 스마트시드 푼토)

K-번호: K180193 · 2018-02-21

결정일2018-02-21

제품 코드GEX

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) 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 2018-02-21 under 510(k) number K180193. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)?

DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) is a medical device that received FDA 510(k) clearance on 2018-02-21. The listed applicant is El.En Electronic Engineering Spa. The 510(k) number is K180193.

When did DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) receive FDA 510(k) clearance?

DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) received FDA 510(k) clearance on 2018-02-21, under 510(k) number K180193.

Who is the listed applicant for DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)?

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 SMARTXIDE Family (Smartxide Touch, Smartxide Punto)?

The FDA product code for DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) is GEX. This falls under the Gastroenterology category.

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