WATCH-PAT MODEL 100S-2


Device Classification Name

ventilatory effort recorder

510(k) Number K080427
Device Name WATCH-PAT MODEL 100S-2
Applicant
ITAMAR MEDICAL
555 thirteenth street, nw
washington, 
DC 
20004

Applicant Contact jonathan kahan
Correspondent
ITAMAR MEDICAL
555 thirteenth street, nw
washington, 
DC 
20004

Correspodent Contact jonathan kahan
Regulation Number 868.2375
Classification Product Code
MNR  
Date Received 02/15/2008
Decision Date 05/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No