FDA 510(k)

Dual Switch

Numéro K : K211605 · 2022-09-22

Date de décision2022-09-22

Code produitGEX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Dual Switch is the device name listed in this FDA 510(k) record. The listed applicant is Laser Engineering, Inc.. It received FDA 510(k) clearance on 2022-09-22 under 510(k) number K211605. 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.

Questions fréquentes

What is the Dual Switch?

Dual Switch is a medical device that received FDA 510(k) clearance on 2022-09-22. The listed applicant is Laser Engineering, Inc.. The 510(k) number is K211605.

When did Dual Switch receive FDA 510(k) clearance?

Dual Switch received FDA 510(k) clearance on 2022-09-22, under 510(k) number K211605.

Who is the listed applicant for Dual Switch?

The FDA 510(k) record lists Laser Engineering, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dual Switch?

The FDA product code for Dual Switch is GEX. This falls under the Gastroenterology category.

Essais cliniques associés

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Source officielle

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