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510(k) K110810

ANASCIENT BREATH MONITOR by Invoy Technologies, LLC — Product Code BZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2011
Date Received
March 23, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Computer, Oxygen-Uptake
Device Class
Class II
Regulation Number
868.1730
Review Panel
AN
Submission Type

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