Cleared Traditional

SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC

K952169 · Intertech Resources, Inc. · Anesthesiology
Jun 1995
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K952169 is an FDA 510(k) clearance for the SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC, a Ventilator, Emergency, Manual (resuscitator) (Class II — Special Controls, product code BTM), submitted by Intertech Resources, Inc. (Fort Myers, US). The FDA issued a Cleared decision on June 8, 1995, 31 days after receiving the submission on May 8, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5915.

Submission Details

510(k) Number K952169 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 1995
Decision Date June 08, 1995
Days to Decision 31 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BTM — Ventilator, Emergency, Manual (resuscitator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5915

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