Cleared Traditional

CADWELL EASYNET NASAL PRESSURE MODULE

K061705 · Cadwell Laboratories, Inc. · Anesthesiology

Nov 2006

Decision

158d

Days

Class 2

Risk

About This 510(k) Submission

K061705 is an FDA 510(k) clearance for the CADWELL EASYNET NASAL PRESSURE MODULE, a Ventilatory Effort Recorder (Class II — Special Controls, product code MNR), submitted by Cadwell Laboratories, Inc. (Kennewick, US). The FDA issued a Cleared decision on November 21, 2006, 158 days after receiving the submission on June 16, 2006. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number	K061705 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 16, 2006
Decision Date	November 21, 2006
Days to Decision	158 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF