SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8

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

The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Suresigns Vm4, Suresigns Vm6, Suresigns Vm8.

Device ID	K123900
510k Number	K123900
Device Name:	SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8
Classification	Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant	PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099
Contact	Mary Kruitwagen
Correspondent	Mary Kruitwagen PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099
Product Code	MHX
Subsequent Product Code	CCK
Subsequent Product Code	DQA
Subsequent Product Code	DRT
Subsequent Product Code	DSA
Subsequent Product Code	DSJ
Subsequent Product Code	DSK
Subsequent Product Code	DXN
Subsequent Product Code	FLL
CFR Regulation Number	870.1025 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Special
3rd Party Reviewed	No
Combination Product	No
Date Received	2012-12-18
Decision Date	2013-04-18
Summary:	summary