Cleared Traditional

Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer

K170663 · Foremount Enterprise Co., Ltd. · Anesthesiology

May 2018

Decision

431d

Days

Class 2

Risk

About This 510(k) Submission

K170663 is an FDA 510(k) clearance for the Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer, a Ventilator, Emergency, Manual (resuscitator) (Class II — Special Controls, product code BTM), submitted by Foremount Enterprise Co., Ltd. (Taichung City, TW). The FDA issued a Cleared decision on May 11, 2018, 431 days after receiving the submission on March 6, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5915.

Submission Details

510(k) Number	K170663 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 06, 2017
Decision Date	May 11, 2018
Days to Decision	431 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF