ZEST PETITE NASAL MASK


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K103786
Device Name ZEST PETITE NASAL MASK
Applicant
FISHER & PAYKEL HEALTHCARE, LTD.
15 maurice paykel place
east tamaki, auckland, 

NZ

2013

Applicant Contact tina mason
Correspondent
FISHER & PAYKEL HEALTHCARE, LTD.
15 maurice paykel place
east tamaki, auckland, 

NZ

2013

Correspodent Contact tina mason
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 12/27/2010
Decision Date 03/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No