510(k) K133961

SURESIGNS VS3, SURESIGNS VS4 by Philips Medical Systems — Product Code DSJ

K133961 is an FDA 510(k) premarket notification submitted by Philips Medical Systems for the device "SURESIGNS VS3, SURESIGNS VS4". The FDA issued a decision of Substantially Equivalent on June 26, 2014. The device falls under product code DSJ (Alarm, Blood-Pressure), a Class II device regulated under 21 CFR 870.1100. Philips Medical Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2014
Date Received
December 24, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alarm, Blood-Pressure
Device Class
Class II
Regulation Number
870.1100
Review Panel
CV
Submission Type