FDA 510(k)

TNI Clear-Guard™ 3 angled breathing filter (1545020)

Numéro K : K223258 · 2023-06-15

Date de décision2023-06-15

Code produitCAH

Comité consultatifAN

DécisionSubstantially Equivalent

Résumé du dispositif

TNI Clear-Guard™ 3 angled breathing filter (1545020) is the device name listed in this FDA 510(k) record. The listed applicant is Intersurgical , Ltd.. It received FDA 510(k) clearance on 2023-06-15 under 510(k) number K223258. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the TNI Clear-Guard™ 3 angled breathing filter (1545020)?

TNI Clear-Guard™ 3 angled breathing filter (1545020) is a medical device that received FDA 510(k) clearance on 2023-06-15. The listed applicant is Intersurgical , Ltd.. The 510(k) number is K223258.

When did TNI Clear-Guard™ 3 angled breathing filter (1545020) receive FDA 510(k) clearance?

TNI Clear-Guard™ 3 angled breathing filter (1545020) received FDA 510(k) clearance on 2023-06-15, under 510(k) number K223258.

Who is the listed applicant for TNI Clear-Guard™ 3 angled breathing filter (1545020)?

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

What is the FDA product code for TNI Clear-Guard™ 3 angled breathing filter (1545020)?

The FDA product code for TNI Clear-Guard™ 3 angled breathing filter (1545020) is CAH.

Essais cliniques associés

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Source officielle

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