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FDA 510(k), K082008, BIONET BM3PLUS PATIENT MONITOR
FDA 510(k), K082008, BIONET BM3PLUS PATIENT MONITOR
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510(K) Number: K082008
Device Name: BIONET BM3PLUS PATIENT MONITOR
Manufacturer: BIONET CO., LTD.
Device Classification Name: monitor, physiological, patient (without arrhythmia detection or alarms)
Regulation Number: 870.2300
Classification Product Code: MWI
Date Received: 07/15/2008
Decision Date: 12/11/2008
Regulation Medical Specialty: Cardiovascular
Device Name: BIONET BM3PLUS PATIENT MONITOR
Manufacturer: BIONET CO., LTD.
Device Classification Name: monitor, physiological, patient (without arrhythmia detection or alarms)
Regulation Number: 870.2300
Classification Product Code: MWI
Date Received: 07/15/2008
Decision Date: 12/11/2008
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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