Cleared Traditional

ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER

K011329 · E. Benson Hood Lab, Inc. · Anesthesiology

Jul 2002

Decision

451d

Days

Class 2

Risk

About This 510(k) Submission

K011329 is an FDA 510(k) clearance for the ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER, a Rhinoanemometer (measurement Of Nasal Decongestion) (Class II — Special Controls, product code BXQ), submitted by E. Benson Hood Lab, Inc. (Pembroke, US). The FDA issued a Cleared decision on July 26, 2002, 451 days after receiving the submission on May 1, 2001. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1800.

Submission Details

510(k) Number	K011329 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2001
Decision Date	July 26, 2002
Days to Decision	451 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF