Cleared Traditional

ANASCIENT BREATH MONITOR

K110810 · Invoy Technologies, LLC · Anesthesiology

Jun 2011

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K110810 is an FDA 510(k) clearance for the ANASCIENT BREATH MONITOR, a Computer, Oxygen-uptake (Class II — Special Controls, product code BZL), submitted by Invoy Technologies, LLC (Chandler, US). The FDA issued a Cleared decision on June 21, 2011, 90 days after receiving the submission on March 23, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1730.

Submission Details

510(k) Number	K110810 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 23, 2011
Decision Date	June 21, 2011
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement