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510(k) K982334

AIRZONE PEAK FLOWMETER by Clement Clarke Intl., Ltd. — Product Code BZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1999
Date Received
July 2, 1998
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 Clement Clarke Intl., Ltd.

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  • K000368 — EYECAP IMAGING SYSTEM (May 4, 2000)
  • K980960 — IN-CHECK INSPIRATORY FLOWMETER (June 10, 1998)
  • K962074 — VM PLUS PEAK FLOWMETER (January 2, 1997)

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