510(k) K210133

Current Health Monitoring System Gen 2 (G2) by Current Health — Product Code MSX

K210133 is an FDA 510(k) premarket notification submitted by Current Health for the device "Current Health Monitoring System Gen 2 (G2)". The FDA issued a decision of Substantially Equivalent on September 3, 2021. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. Current Health has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2021
Date Received
January 19, 2021
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