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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 K992618
Device Name RESPALERT
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 Received08/04/1999
Decision Date 10/29/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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