FDA 510(k)

Global Med Systems Milesman Compact Laser

Numéro K : K203804 · 2021-02-23

Date de décision2021-02-23

Code produitGEX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Global Med Systems Milesman Compact Laser is the device name listed in this FDA 510(k) record. The listed applicant is Global Med Systems SL. It received FDA 510(k) clearance on 2021-02-23 under 510(k) number K203804. 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 Global Med Systems Milesman Compact Laser?

Global Med Systems Milesman Compact Laser is a medical device that received FDA 510(k) clearance on 2021-02-23. The listed applicant is Global Med Systems SL. The 510(k) number is K203804.

When did Global Med Systems Milesman Compact Laser receive FDA 510(k) clearance?

Global Med Systems Milesman Compact Laser received FDA 510(k) clearance on 2021-02-23, under 510(k) number K203804.

Who is the listed applicant for Global Med Systems Milesman Compact Laser?

The FDA 510(k) record lists Global Med Systems SL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Global Med Systems Milesman Compact Laser?

The FDA product code for Global Med Systems Milesman Compact Laser is GEX. This falls under the Gastroenterology category.

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Source officielle

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