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: K113653
• 510k Number: K113653
• Device Name: PATIENT MONITOR
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: EDAN INSTRUMENTS, INC. EQUIPMENTS PARK, NANHAI RD 1019 NO. Shenzhen, CN 518067
• Contact: Randy Jiang
• Correspondent: Randy Jiang; EDAN INSTRUMENTS, INC. EQUIPMENTS PARK, NANHAI RD 1019 NO. Shenzhen, CN 518067
• Product Code: MHX
• Subsequent Product Code: DQA
• Subsequent Product Code: DRT
• Subsequent Product Code: DSA
• Subsequent Product Code: DSI
• Subsequent Product Code: DSK
• Subsequent Product Code: DXN
• Subsequent Product Code: FLL
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-12-12
• Decision Date: 2012-02-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00815871022156	K113653	000