Arm Blood Pressure Monitor

System, Measurement, Blood-pressure, Non-invasive

Alicn Medical (Shenzhen), Inc

The following data is part of a premarket notification filed by Alicn Medical (shenzhen), Inc with the FDA for Arm Blood Pressure Monitor.

Pre-market Notification Details

• Device ID: K180435
• 510k Number: K180435
• Device Name: Arm Blood Pressure Monitor
• Classification: System, Measurement, Blood-pressure, Non-invasive
• Applicant: Alicn Medical (Shenzhen), Inc 4/F, B Building, Shenfubao Modern Optical Factory Kengzi Street, Pingshan Dist Shezhen, CN 518122
• Contact: Meisong Fang
• Correspondent: Meisong Fang; Alicn Medical (Shenzhen), Inc 4/F, B Building, Shenfubao Modern Optical Factory Kengzi Street, Pingshan Dist Shezhen, CN 518122
• Product Code: DXN
• CFR Regulation Number: 870.1130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-02-20
• Decision Date: 2019-01-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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