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510(k) K042058

ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN by Clement Clarke Intl., Ltd. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2005
Date Received
July 30, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Diagnostic
Device Class
Class II
Regulation Number
868.1840
Review Panel
AN
Submission Type

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  • K980960 — IN-CHECK INSPIRATORY FLOWMETER (June 10, 1998)
  • K962074 — VM PLUS PEAK FLOWMETER (January 2, 1997)

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