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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 K040862
Device Name GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM
Applicant
CARADYNE, LTD.
PARKMORE BUSINESS PARK,
PARKMORE WEST
GALWAY,  IE
Applicant Contact JOHN O'DEA
Correspondent
CARADYNE, LTD.
PARKMORE BUSINESS PARK,
PARKMORE WEST
GALWAY,  IE
Correspondent Contact JOHN O'DEA
Regulation Number868.5905
Classification Product Code
BZD  
Date Received04/02/2004
Decision Date 06/30/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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