Cleared Traditional

K963347 - REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142
(FDA 510(k) Clearance)

K963347 · Instrumentation Industries, Inc. · Anesthesiology

Mar 1997

Decision

205d

Days

Class 2

Risk

K963347 is an FDA 510(k) clearance for the REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142, a Attachment, Breathing, Positive End Expiratory Pressure (Class II — Special Controls, product code BYE), submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on March 19, 1997, 205 days after receiving the submission on August 26, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5965.

Submission Details

510(k) Number	K963347 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 26, 1996
Decision Date	March 19, 1997
Days to Decision	205 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement