SURESIGNS VS2+ -SURESIGNS VSI

System, Measurement, Blood-pressure, Non-invasive

The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Suresigns Vs2+ -suresigns Vsi.

Device ID	K112652
510k Number	K112652
Device Name:	SURESIGNS VS2+ -SURESIGNS VSI
Classification	System, Measurement, Blood-pressure, Non-invasive
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	DXN
Subsequent Product Code	DQA
Subsequent Product Code	DSA
Subsequent Product Code	DSJ
Subsequent Product Code	DSK
Subsequent Product Code	DXG
Subsequent Product Code	FLL
CFR Regulation Number	870.1130 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Special
3rd Party Reviewed	No
Combination Product	No
Date Received	2011-09-12
Decision Date	2011-10-11
Summary:	summary