Patient Monitor

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

Edan Instruments, Inc.

The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Patient Monitor.

Pre-market Notification Details

• Device ID: K192514
• 510k Number: K192514
• Device Name: Patient Monitor
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, CN 518122
• Contact: Alice Yang
• Correspondent: Alice Yang; Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, CN 518122
• Product Code: MHX
• Subsequent Product Code: CCK
• Subsequent Product Code: DPS
• 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: 2019-09-12
• Decision Date: 2020-04-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06944413810945	K192514	000
06944413810921	K192514	000
06944413810907	K192514	000