Cleared Traditional

IMPACT MODEL 753

K931473 · Impact Instrumentation, Inc. · Anesthesiology
Dec 1994
Decision
646d
Days
Class 2
Risk

About This 510(k) Submission

K931473 is an FDA 510(k) clearance for the IMPACT MODEL 753, a Ventilator, Emergency, Powered (resuscitator) (Class II — Special Controls, product code BTL), submitted by Impact Instrumentation, Inc. (West Caldwell, US). The FDA issued a Cleared decision on December 30, 1994, 646 days after receiving the submission on March 24, 1993. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5925.

Submission Details

510(k) Number K931473 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 1993
Decision Date December 30, 1994
Days to Decision 646 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

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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