DUAL HEATED INFANT VREATHING CIROUITS


Device Classification Name

heater, breathing system w/wo controller (not humidifier or nebulizer

510(k) Number K103767
Device Name DUAL HEATED INFANT VREATHING CIROUITS
Applicant
FISHER & PAYKEL HEALTHCARE LTD.
15 maurice paykel place
po box 14648
auckland, 

NZ

1071

Applicant Contact robert petry
Correspondent
FISHER & PAYKEL HEALTHCARE LTD.
15 maurice paykel place
po box 14648
auckland, 

NZ

1071

Correspodent Contact robert petry
Regulation Number 868.5270
Classification Product Code
BZE  
Date Received 12/23/2010
Decision Date 04/16/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No