Cleared Traditional

POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE

K905697 · Impact Instrumentation, Inc. · Anesthesiology
Dec 1990
Decision
3d
Days
Class 2
Risk

About This 510(k) Submission

K905697 is an FDA 510(k) clearance for the POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE, 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 27, 1990, 3 days after receiving the submission on December 24, 1990. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5925.

Submission Details

510(k) Number K905697 FDA.gov
FDA Decision Cleared SESE
Date Received December 24, 1990
Decision Date December 27, 1990
Days to Decision 3 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

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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