Cleared Traditional

Prestige Ameritech Pediatric/Child?s Face mask

K160100 · Prestige Ameritech · General Hospital

Oct 2016

Decision

262d

Days

Class 2

Risk

About This 510(k) Submission

K160100 is an FDA 510(k) clearance for the Prestige Ameritech Pediatric/Child?s Face mask, a Pediatric/child Facemask (Class II — Special Controls, product code OXZ), submitted by Prestige Ameritech (North Richland Hills, US). The FDA issued a Cleared decision on October 7, 2016, 262 days after receiving the submission on January 19, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K160100 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 19, 2016
Decision Date	October 07, 2016
Days to Decision	262 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	OXZ — Pediatric/child Facemask
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4040
Definition	A Pediatric/child Facemask Is Intended To Be Worn By The Patient/child To Provide Protection For The Respiratory Tract. It Is A Single Use, Disposable Device That Is Provided Non-sterile. The Facemask Is Recommended For Use In A Healthcare Setting With Appropriate Adult Supervision.