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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