510(k) K141756

INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION by Draeger Medical Systems, Inc. — Product Code MSX

K141756 is an FDA 510(k) premarket notification submitted by Draeger Medical Systems, Inc. for the device "INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION". The FDA issued a decision of Substantially Equivalent on December 12, 2014. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. Draeger Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2014
Date Received
June 30, 2014
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