AMBU ASCOPE 2


Device Classification Name

tube, tracheal (w/wo connector)

510(k) Number K110962
Device Name AMBU ASCOPE 2
Applicant
AMBU A/S
6740 baymeadow dr.
glen burnie, 
MD 
21060

Applicant Contact sanjay parikh
Correspondent
AMBU A/S
6740 baymeadow dr.
glen burnie, 
MD 
21060

Correspodent Contact sanjay parikh
Regulation Number 868.5730
Classification Product Code
BTR  
Date Received 04/06/2011
Decision Date 11/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No