FDA 510(k)

AI100 avec Shonit

Numéro K : K221309 · 2023-09-19

DemandeurSigtuple Technologies Pvt. , Ltd.

Date de décision2023-09-19

Code produitJOY

Comité consultatifHE

DécisionSubstantially Equivalent

Résumé du dispositif

AI100 with Shonit is the device name listed in this FDA 510(k) record. The listed applicant is Sigtuple Technologies Pvt. , Ltd.. It received FDA 510(k) clearance on 2023-09-19 under 510(k) number K221309. The device is classified under product code JOY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the AI100 with Shonit?

AI100 with Shonit is a medical device that received FDA 510(k) clearance on 2023-09-19. The listed applicant is Sigtuple Technologies Pvt. , Ltd.. The 510(k) number is K221309.

When did AI100 with Shonit receive FDA 510(k) clearance?

AI100 with Shonit received FDA 510(k) clearance on 2023-09-19, under 510(k) number K221309.

Who is the listed applicant for AI100 with Shonit?

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

What is the FDA product code for AI100 with Shonit?

The FDA product code for AI100 with Shonit is JOY.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Dispositifs connexes (Code : JOY)

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Source officielle

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