Cleared Traditional

T-PIECE RESUSCITATOR

K142096 · Mercury Medical · Anesthesiology
Oct 2014
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K142096 is an FDA 510(k) clearance for the T-PIECE RESUSCITATOR, a Ventilator, Emergency, Powered (resuscitator) (Class II — Special Controls, product code BTL), submitted by Mercury Medical (Bonita Springs, US). The FDA issued a Cleared decision on October 17, 2014, 77 days after receiving the submission on August 1, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5925.

Submission Details

510(k) Number K142096 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2014
Decision Date October 17, 2014
Days to Decision 77 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTL — Ventilator, Emergency, Powered (resuscitator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5925

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