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510(k) K082008

BIONET BM3PLUS PATIENT MONITOR by Bionet Co., Ltd. — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2008
Date Received
July 15, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

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  • K043598 — FC 1400 FETAL MONITOR (December 16, 2005)
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