FDA 510(k)

Convaid Flyer FL12, FL13, FL14, FL15 et FL16 ; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T et FL16T

Numéro K : K171017 · 2017-10-18

Date de décision2017-10-18

Code produitIOR

Comité consultatifPolitique : medical-regulatory-v1. Politique : medical-regulatory-v1.

DécisionÉquivalence substantielle

Résumé du dispositif

Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T is the device name listed in this FDA 510(k) record. The listed applicant is Convaid Products, LLC. It received FDA 510(k) clearance on 2017-10-18 under 510(k) number K171017. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T?

Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T is a medical device that received FDA 510(k) clearance on 2017-10-18. The listed applicant is Convaid Products, LLC. The 510(k) number is K171017.

When did Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T receive FDA 510(k) clearance?

Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T received FDA 510(k) clearance on 2017-10-18, under 510(k) number K171017.

Who is the listed applicant for Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T?

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

What is the FDA product code for Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T?

The FDA product code for Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T is IOR.

Essais cliniques associés

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Source officielle

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