Cleared Traditional

K991785 - MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR
(FDA 510(k) Clearance)

K991785 · Instrumentation Industries, Inc. · Anesthesiology

Aug 1999

Decision

84d

Days

Class 2

Risk

K991785 is an FDA 510(k) clearance for the MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR, a Ventilator, Emergency, Powered (resuscitator) (Class II — Special Controls, product code BTL), submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on August 17, 1999, 84 days after receiving the submission on May 25, 1999. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5925.

Submission Details

510(k) Number	K991785 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 25, 1999
Decision Date	August 17, 1999
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement