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510(k) K130322

SPM-300 by Bionet Co., Ltd. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2013
Date Received
February 8, 2013
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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