IM60/IM70 PATIENT MONITOR

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

The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Im60/im70 Patient Monitor.

Device ID	K131971
510k Number	K131971
Device Name:	IM60/IM70 PATIENT MONITOR
Classification	Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant	EDAN INSTRUMENTS, INC. NANHAI RD 1019 NO. SHEKOU, NANSHAN Shenzhen, Guangdong, CN 518067
Contact	Cherry Sun
Correspondent	Cherry Sun EDAN INSTRUMENTS, INC. NANHAI RD 1019 NO. SHEKOU, NANSHAN Shenzhen, Guangdong, CN 518067
Product Code	MHX
Subsequent Product Code	CBQ
Subsequent Product Code	CBR
Subsequent Product Code	CBS
Subsequent Product Code	CCK
Subsequent Product Code	CCL
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
Subsequent Product Code	MLD
CFR Regulation Number	870.1025 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Traditional
3rd Party Reviewed	No
Combination Product	No
Date Received	2013-06-28
Decision Date	2014-03-20
Summary:	summary