Cleared Traditional

A1 ACOUSTIC RHINOMETER

K972140 · G.M. Instruments , Ltd. · Anesthesiology

Sep 1998

Decision

481d

Days

Class 2

Risk

About This 510(k) Submission

K972140 is an FDA 510(k) clearance for the A1 ACOUSTIC RHINOMETER, a Rhinoanemometer (measurement Of Nasal Decongestion) (Class II — Special Controls, product code BXQ), submitted by G.M. Instruments , Ltd. (Kilwinning, GB). The FDA issued a Cleared decision on September 30, 1998, 481 days after receiving the submission on June 6, 1997. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1800.

Submission Details

510(k) Number	K972140 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 06, 1997
Decision Date	September 30, 1998
Days to Decision	481 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement