FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K080209
Device Name FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK
Applicant
FISHER & PAYKEL HEALTHCARE, LTD.
p.o. box 14-348
auckland, 

NZ

Applicant Contact tina mason
Correspondent
FISHER & PAYKEL HEALTHCARE, LTD.
p.o. box 14-348
auckland, 

NZ

Correspodent Contact tina mason
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 01/28/2008
Decision Date 09/12/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No