Cleared Traditional

RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE

K000406 · Rhino Metrics A/S · Anesthesiology

Apr 2000

Decision

70d

Days

Class 2

Risk

About This 510(k) Submission

K000406 is an FDA 510(k) clearance for the RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE, a Rhinoanemometer (measurement Of Nasal Decongestion) (Class II — Special Controls, product code BXQ), submitted by Rhino Metrics A/S (Washington, US). The FDA issued a Cleared decision on April 17, 2000, 70 days after receiving the submission on February 7, 2000. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1800.

Submission Details

510(k) Number	K000406 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 07, 2000
Decision Date	April 17, 2000
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF