EMBLETTA GOLD


Device Classification Name

ventilatory effort recorder

510(k) Number K073682
Device Name EMBLETTA GOLD
Applicant
EMBLA SYSTEMS, INC.
11001 w. 120th ave.
broomfield, 
CO 
80021

Applicant Contact robert g schueppert
Correspondent
EMBLA SYSTEMS, INC.
11001 w. 120th ave.
broomfield, 
CO 
80021

Correspodent Contact robert g schueppert
Regulation Number 868.2375
Classification Product Code
MNR  
Date Received 12/28/2007
Decision Date 08/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls