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510(k) K992618

RESPALERT by Harwill Medical (Pty) , Ltd. — Product Code BZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1999
Date Received
August 4, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Meter, Peak Flow, Spirometry
Device Class
Class II
Regulation Number
868.1860
Review Panel
AN
Submission Type

Other clearances by Harwill Medical (Pty) , Ltd.

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  • K980550 — WHISTLE WATCH (August 27, 1998)

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