MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU

Device Classification Name

humidifier, respiratory gas, (direct patient interface)

510(k) Number K033710
Device Name MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU
Applicant
FISHER & PAYKEL HEALTHCARE, LTD.
p.o box 14-348
panmure, auckland, 

NZ

1701

Applicant Contact brett whiston
Regulation Number 868.5450
Classification Product Code
BTT  
Date Received 11/26/2003
Decision Date 04/13/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No