FDA 510(k)

Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle

Numéro K : K252033 · 2025-07-25

Date de décision2025-07-25

Code produitFMF

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle is the device name listed in this FDA 510(k) record. The listed applicant is CMT Health PTE., Ltd.. It received FDA 510(k) clearance on 2025-07-25 under 510(k) number K252033. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle?

Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle is a medical device that received FDA 510(k) clearance on 2025-07-25. The listed applicant is CMT Health PTE., Ltd.. The 510(k) number is K252033.

When did Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle receive FDA 510(k) clearance?

Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle received FDA 510(k) clearance on 2025-07-25, under 510(k) number K252033.

Who is the listed applicant for Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle?

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

What is the FDA product code for Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle?

The FDA product code for Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle is FMF.

Essais cliniques associés

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Autres dossiers indiquant CMT Health PTE., Ltd. en tant que demandeur

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Dispositifs connexes (Code : FMF)

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Source officielle

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