Cleared Traditional

K970959 - INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT)
(FDA 510(k) Clearance)

K970959 · Instrumentation Industries, Inc. · Anesthesiology

Jun 1997

Decision

88d

Days

Class 2

Risk

K970959 is an FDA 510(k) clearance for the INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT). This device is classified as a Ventilator, Emergency, Manual (resuscitator) (Class II — Special Controls, product code BTM).

Submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on June 13, 1997, 88 days after receiving the submission on March 17, 1997.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5915.

Submission Details

510(k) Number	K970959 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 17, 1997
Decision Date	June 13, 1997
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement