510(k) K243270

TigerConnect Alarm Management by Tigerconnect — Product Code MSX

K243270 is an FDA 510(k) premarket notification submitted by Tigerconnect for the device "TigerConnect Alarm Management". The FDA issued a decision of Substantially Equivalent on September 30, 2025. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2025
Date Received
October 16, 2024
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