BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

Shenzhen Mindray Bio-medical Electronics Co., LTD.

The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd. with the FDA for Benevision N Series Patient Monitors (including Benevision N12, Benevision N15, Benevision N17, Benevision N19. Benevision N22, Benevision N1).

Pre-market Notification Details

• Device ID: K182075
• 510k Number: K182075
• Device Name: BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: Shenzhen Mindray Bio-medical Electronics Co., LTD. Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen, TW 518057
• Contact: Yanhong Bai
• Correspondent: Yanhong Bai; Shenzhen Mindray Bio-medical Electronics Co., LTD. Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen, TW 518057
• Product Code: MHX
• Subsequent Product Code: DQA
• Subsequent Product Code: DRT
• Subsequent Product Code: DSI
• Subsequent Product Code: DSK
• Subsequent Product Code: DXN
• Subsequent Product Code: FLL
• Subsequent Product Code: MLD
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-08-01
• Decision Date: 2018-12-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06936415902643	K182075	000
06936415905552	K182075	000
06936415905569	K182075	000
06936415905583	K182075	000
06944904000183	K182075	000
06944904000190	K182075	000
06944904000206	K182075	000
06944904094908	K182075	000
06944904094915	K182075	000
06936415905507	K182075	000
06936415905545	K182075	000
06936415905538	K182075	000
06936415903893	K182075	000
06936415904043	K182075	000
06944904091969	K182075	000
06936415903800	K182075	000
06944904091716	K182075	000
06936415902674	K182075	000
06936415902698	K182075	000
06936415902728	K182075	000
06936415902735	K182075	000
06936415902759	K182075	000
06936415905576	K182075	000
06936415905590	K182075	000
06944904091945	K182075	000
06944904091952	K182075	000
06944904092492	K182075	000
06944904061108	K182075	000
06944904090573	K182075	000
06944904090580	K182075	000
06944904090603	K182075	000
06944904091938	K182075	000
06944904097992	K182075	000
06936415912604	K182075	000
06936415902704	K182075	000
06936415901929	K182075	000
06936415919139	K182075	000
06944904096766	K182075	000
06944904096841	K182075	000
06936415901752	K182075	000
06936415901769	K182075	000
06936415901776	K182075	000
06936415901783	K182075	000
06936415901806	K182075	000
06936415901837	K182075	000
06936415904074	K182075	000