Cleared Traditional

COLLINS DIGITAL PULMONARY MANOMETER

K912946 · Warren E. Collins, Inc. · Anesthesiology
Jan 1992
Decision
194d
Days
Class 2
Risk

About This 510(k) Submission

K912946 is an FDA 510(k) clearance for the COLLINS DIGITAL PULMONARY MANOMETER, a Meter, Airway Pressure (inspiratory Force) (Class II — Special Controls, product code BXR), submitted by Warren E. Collins, Inc. (Braintree, US). The FDA issued a Cleared decision on January 15, 1992, 194 days after receiving the submission on July 5, 1991. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1780.

Submission Details

510(k) Number K912946 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 1991
Decision Date January 15, 1992
Days to Decision 194 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BXR — Meter, Airway Pressure (inspiratory Force)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1780

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