Cleared Traditional

RHINOSTREAM RHINOMANOMETER MODULE

K022311 · Rhino Metrics A/S · Anesthesiology

Oct 2002

Decision

79d

Days

Class 2

Risk

About This 510(k) Submission

K022311 is an FDA 510(k) clearance for the RHINOSTREAM RHINOMANOMETER MODULE, a Rhinoanemometer (measurement Of Nasal Decongestion) (Class II — Special Controls, product code BXQ), submitted by Rhino Metrics A/S (Minneapolis, US). The FDA issued a Cleared decision on October 4, 2002, 79 days after receiving the submission on July 17, 2002. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1800.

Submission Details

510(k) Number	K022311 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 17, 2002
Decision Date	October 04, 2002
Days to Decision	79 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF