TASMAN


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K112393
Device Name TASMAN
Applicant
RESMED LTD.
9001 spectrum center blvd.
san diego, 
CA 
92123

Applicant Contact david d’cruz
Correspondent
RESMED LTD.
9001 spectrum center blvd.
san diego, 
CA 
92123

Correspodent Contact david d’cruz
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 08/19/2011
Decision Date 11/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No