ADULT EVAQUA 2′ DUAL HEATED BREATHING CIRCUITS


Device Classification Name

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

510(k) Number K122432
Device Name ADULT EVAQUA 2′ DUAL HEATED BREATHING CIRCUITS
Applicant
FISHER & PAYKEL HEALTHCARE, LTD.
15 maurice paykel place
east tamaki, 

NZ

2013

Applicant Contact robert petry
Correspondent
FISHER & PAYKEL HEALTHCARE, LTD.
15 maurice paykel place
east tamaki, 

NZ

2013

Correspodent Contact robert petry
Regulation Number 868.5270
Classification Product Code
BZE  
Date Received 08/10/2012
Decision Date 12/06/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No