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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Meter, Peak Flow, Spirometry
510(k) Number K980550
Device Name WHISTLE WATCH
Applicant
Harwill Medical (Pty) , Ltd.
P.O. Box 4341
Crofton,  MD  21114
Applicant Contact E.J. Smith
Correspondent
Harwill Medical (Pty) , Ltd.
P.O. Box 4341
Crofton,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number868.1860
Classification Product Code
BZH  
Date Received02/12/1998
Decision Date 08/27/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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