FDA 510(k)

MonoStereo

Numéro K : K234096 · 2024-09-19

Date de décision2024-09-19

Code produitEOB

Comité consultatifEN

DécisionSubstantially Equivalent

Résumé du dispositif

MonoStereo is the device name listed in this FDA 510(k) record. The listed applicant is Medicaltek Co., Ltd.. It received FDA 510(k) clearance on 2024-09-19 under 510(k) number K234096. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the MonoStereo?

MonoStereo is a medical device that received FDA 510(k) clearance on 2024-09-19. The listed applicant is Medicaltek Co., Ltd.. The 510(k) number is K234096.

When did MonoStereo receive FDA 510(k) clearance?

MonoStereo received FDA 510(k) clearance on 2024-09-19, under 510(k) number K234096.

Who is the listed applicant for MonoStereo?

The FDA 510(k) record lists Medicaltek Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MonoStereo?

The FDA product code for MonoStereo is EOB.

Essais cliniques associés

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Source officielle

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