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FDA 510(k) Applications Submitted by CARADYNE, LTD.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K040862
04/02/2004
GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM
CARADYNE, LTD.
K000959
03/24/2000
CRITERION 60 OR PM 60
CARADYNE, LTD.
K023565
10/23/2002
OXICHECK
CARADYNE, LTD.
K992101
06/22/1999
CRITERION 40 OR PM 40
CARADYNE, LTD.
K982283
06/30/1998
WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH
CARADYNE, LTD.
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