FDA 510(k)

TEMED Gas Diffuser

Numéro K : K173545 · 2018-02-14

DemandeurTemed

Date de décision2018-02-14

Code produitHIF

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

TEMED Gas Diffuser is the device name listed in this FDA 510(k) record. The listed applicant is Temed. It received FDA 510(k) clearance on 2018-02-14 under 510(k) number K173545. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the TEMED Gas Diffuser?

TEMED Gas Diffuser is a medical device that received FDA 510(k) clearance on 2018-02-14. The listed applicant is Temed. The 510(k) number is K173545.

When did TEMED Gas Diffuser receive FDA 510(k) clearance?

TEMED Gas Diffuser received FDA 510(k) clearance on 2018-02-14, under 510(k) number K173545.

Who is the listed applicant for TEMED Gas Diffuser?

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

What is the FDA product code for TEMED Gas Diffuser?

The FDA product code for TEMED Gas Diffuser is HIF.

Essais cliniques associés

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Dispositifs connexes (Code : HIF)

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Source officielle

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