MDRIVE


Device Classification Name

ventilatory effort recorder

510(k) Number K111742
Device Name MDRIVE
Applicant
EMBLA SYSTEMS
9351 grant street
suite 600
thornton, 
CO 
80229

Applicant Contact robert g schueppert
Correspondent
EMBLA SYSTEMS
9351 grant street
suite 600
thornton, 
CO 
80229

Correspodent Contact robert g schueppert
Regulation Number 868.2375
Classification Product Code
MNR  
Date Received 06/21/2011
Decision Date 08/31/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No