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510(k) K091853

WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014 by Nspire Health, Inc. — Product Code BZK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2009
Date Received
June 23, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Monitoring (W/Wo Alarm)
Device Class
Class II
Regulation Number
868.1850
Review Panel
AN
Submission Type

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