Cleared Traditional

MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER

K032593 · Mercury Medical · Anesthesiology

Feb 2004

Decision

165d

Days

Class 2

Risk

About This 510(k) Submission

K032593 is an FDA 510(k) clearance for the MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER, a Meter, Airway Pressure (inspiratory Force) (Class II — Special Controls, product code BXR), submitted by Mercury Medical (Clearwater, US). The FDA issued a Cleared decision on February 3, 2004, 165 days after receiving the submission on August 22, 2003. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1780.

Submission Details

510(k) Number	K032593 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 22, 2003
Decision Date	February 03, 2004
Days to Decision	165 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF