510(k) K182637

Philips IntelliVue XDS Software by Philips Medizin Systeme Boeblingen GmbH — Product Code MSX

K182637 is an FDA 510(k) premarket notification submitted by Philips Medizin Systeme Boeblingen GmbH for the device "Philips IntelliVue XDS Software". The FDA issued a decision of Substantially Equivalent on April 26, 2019. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. Philips Medizin Systeme Boeblingen GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2019
Date Received
September 24, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Network And Communication, Physiological Monitors
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type