FDA 510(k)

Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit

Numéro K : K153506 · 2016-05-06

Date de décision2016-05-06

Code produitKNT

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit is the device name listed in this FDA 510(k) record. The listed applicant is Consure Medical Pvt , Ltd.. It received FDA 510(k) clearance on 2016-05-06 under 510(k) number K153506. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit?

Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit is a medical device that received FDA 510(k) clearance on 2016-05-06. The listed applicant is Consure Medical Pvt , Ltd.. The 510(k) number is K153506.

When did Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit receive FDA 510(k) clearance?

Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit received FDA 510(k) clearance on 2016-05-06, under 510(k) number K153506.

Who is the listed applicant for Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit?

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

What is the FDA product code for Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit?

The FDA product code for Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit is KNT.

Essais cliniques associés

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Dispositifs connexes (Code : KNT)

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Source officielle

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