510(k) K202497

Aulisa Multiple Patient Digital Vital Sign Monitoring System by Taiwan Aulisa Medical Devices Technologies, Inc. — Product Code MSX

K202497 is an FDA 510(k) premarket notification submitted by Taiwan Aulisa Medical Devices Technologies, Inc. for the device "Aulisa Multiple Patient Digital Vital Sign Monitoring System". The FDA issued a decision of Substantially Equivalent on October 30, 2020. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. Taiwan Aulisa Medical Devices Technologies, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2020
Date Received
August 31, 2020
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