RESPIRATORY HUMIDIFER


Device Classification Name

humidifier, respiratory gas, (direct patient interface)

510(k) Number K110019
Device Name RESPIRATORY HUMIDIFER
Applicant
FISHER & PAYKEL HEALTHCARE, LTD.
15 maurice paykel place
p.o. box 14348, panmure
auckland, 

NZ

1741

Applicant Contact adele bindon
Correspondent
FISHER & PAYKEL HEALTHCARE, LTD.
15 maurice paykel place
p.o. box 14348, panmure
auckland, 

NZ

1741

Correspodent Contact adele bindon
Regulation Number 868.5450
Classification Product Code
BTT  
Date Received 01/03/2011
Decision Date 03/30/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No