510(k) K190624

EarlyVue VS30 by Philips Medizin Systeme Boeblingen GmbH — Product Code DSJ

K190624 is an FDA 510(k) premarket notification submitted by Philips Medizin Systeme Boeblingen GmbH for the device "EarlyVue VS30". The FDA issued a decision of Substantially Equivalent on October 27, 2019. The device falls under product code DSJ (Alarm, Blood-Pressure), a Class II device regulated under 21 CFR 870.1100. Philips Medizin Systeme Boeblingen GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2019
Date Received
March 11, 2019
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