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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Attachment, Breathing, Positive End Expiratory Pressure
510(k) Number K982283
Device Name WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH
Applicant
Caradyne, Ltd.
6329 W. Waterview Ct.
Mccordsville,  IN  46055
Applicant Contact PAUL E DRYDEN
Correspondent
Caradyne, Ltd.
6329 W. Waterview Ct.
Mccordsville,  IN  46055
Correspondent Contact PAUL E DRYDEN
Regulation Number868.5965
Classification Product Code
BYE  
Date Received06/30/1998
Decision Date 03/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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