COUGHASSIST T70 DEVICE


Device Classification Name

device, positive pressure breathing, intermittent

510(k) Number K121955
Device Name COUGHASSIST T70 DEVICE
Applicant
RESPIRONICS, INC.
1740 golden mile highway
monroeville, 
PA 
15146

Applicant Contact colleen witt
Correspondent
RESPIRONICS, INC.
1740 golden mile highway
monroeville, 
PA 
15146

Correspodent Contact colleen witt
Regulation Number 868.5905
Classification Product Code
NHJ  
Date Received 07/03/2012
Decision Date 12/14/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No