VPAP S-A


Device Classification Name

ventilator, continuous, non-life-supporting

510(k) Number K122324
Device Name VPAP S-A
Applicant
RESMED LTD.
9001 spectrum center blvd.
san diego, 
CA 
92123

Applicant Contact jim cassi
Correspondent
RESMED LTD.
9001 spectrum center blvd.
san diego, 
CA 
92123

Correspodent Contact jim cassi
Regulation Number 868.5895
Classification Product Code
MNS  
Date Received 08/01/2012
Decision Date 11/13/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No