SLEEPSTYLE 200 AUTO SERIES HC254


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K081029
Device Name SLEEPSTYLE 200 AUTO SERIES HC254
Applicant
FISHER & PAYKEL HEALTHCARE, LTD.
15 maurice paykel place
east tamaki, 

NZ

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

NZ

Correspodent Contact james thompson
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 04/11/2008
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