FDA 510(k), K182075, BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)
FDA 510(k), K182075, BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)
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510(K) Number: K182075
Device Name: BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)
Manufacturer: Shenzhen Mindray Bio-medical Electronics Co., LTD.
Device Classification Name: monitor, physiological, patient(with arrhythmia detection or alarms)
Regulation Number: 870.1025
Classification Product Code: MHX
Date Received: 08/01/2018
Decision Date: 12/10/2018
Regulation Medical Specialty: Cardiovascular
Device Name: BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)
Manufacturer: Shenzhen Mindray Bio-medical Electronics Co., LTD.
Device Classification Name: monitor, physiological, patient(with arrhythmia detection or alarms)
Regulation Number: 870.1025
Classification Product Code: MHX
Date Received: 08/01/2018
Decision Date: 12/10/2018
Regulation Medical Specialty: Cardiovascular
- 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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