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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K063036
Device Name OPUS HC482 DIRECT NASAL MASK
Applicant
FISHER & PAYKEL HEALTHCARE, LTD.
15 MAURICE PAYKEL PLACE
EAST TAMAKI, AUCKLAND,  NZ 2013
Applicant Contact JAYANTI KARANDIKAR
Correspondent
FISHER & PAYKEL HEALTHCARE, LTD.
15 MAURICE PAYKEL PLACE
EAST TAMAKI, AUCKLAND,  NZ 2013
Correspondent Contact JAYANTI KARANDIKAR
Regulation Number868.5905
Classification Product Code
BZD  
Date Received10/03/2006
Decision Date 12/22/2006
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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