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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, continuous, minimal ventilatory support, facility use
510(k) Number K060044
Device Name ACUTE CARE FACE MASK, MODEL RT040
Applicant
FISHER & PAYKEL HEALTHCARE, LTD.
P.O BOX 14-348
PANMURE, AUCKLAND,  NZ 1701
Applicant Contact BRETT WHISTON
Correspondent
FISHER & PAYKEL HEALTHCARE, LTD.
P.O BOX 14-348
PANMURE, AUCKLAND,  NZ 1701
Correspondent Contact BRETT WHISTON
Regulation Number868.5895
Classification Product Code
MNT  
Date Received01/06/2006
Decision Date 04/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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