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: K160981
• 510k Number: K160981
• Device Name: Patient Monitor
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: EDAN INSTRUMENTS, INC. 3/F - B, NANSHAN MEDICAL EQUIPMENTS PARK NANHAI RD 1019# Shenzhen, CN 518067
• Contact: Queena Chen
• Correspondent: Doug Worth; EDAN MEDICAL 1200 CROSSMAN AVE. SUITE 200 Sunnyvale, CA 94089
• Product Code: MHX
• Subsequent Product Code: BZK
• Subsequent Product Code: BZQ
• Subsequent Product Code: CBQ
• Subsequent Product Code: CBR
• Subsequent Product Code: CBS
• Subsequent Product Code: CCK
• Subsequent Product Code: CCL
• Subsequent Product Code: DPS
• Subsequent Product Code: DQA
• Subsequent Product Code: DRG
• Subsequent Product Code: DRT
• Subsequent Product Code: DSB
• Subsequent Product Code: DSI
• Subsequent Product Code: DSK
• Subsequent Product Code: DXN
• Subsequent Product Code: FLL
• Subsequent Product Code: MLD
• Subsequent Product Code: NHO
• Subsequent Product Code: NHP
• Subsequent Product Code: &nb
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-04-07
• Decision Date: 2016-12-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06944413802162	K160981	000
06944413802155	K160981	000