ANASCIENT BREATH MONITOR


Device Classification Name

computer, oxygen-uptake

510(k) Number K110810
Device Name ANASCIENT BREATH MONITOR
Applicant
INVOY TECHNOLOGIES, LLC
1820 e.ray road
chandler, 
AZ 
85225

Applicant Contact lubna m ahmad
Regulation Number 868.1730
Classification Product Code
BZL  
Date Received 03/23/2011
Decision Date 06/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

statement

statement

Type Traditional
Reviewed by Third Party Yes

Combination Product

No