ORACLE ORAL MASK, MODEL HC451A


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K033087
Device Name ORACLE ORAL MASK, MODEL HC451A
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 09/29/2003
Decision Date 01/14/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls