SINGLE USE ORAL MASK, MODEL HC455A


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K023670
Device Name SINGLE USE ORAL MASK, MODEL HC455A
Original Applicant
FISHER & PAYKEL HEALTHCARE, LTD.
15 maurice paykel place
east tamaki, auckland, 

NZ

Original Contact robert petry
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 10/31/2002
Decision Date 06/12/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No