Cleared Traditional

K202497 - Aulisa Multiple Patient Digital Vital Sign Monitoring System (FDA 510(k) Clearance)

K202497 · Taiwan Aulisa Medical Devices Technologies, Inc. · Cardiovascular device

Oct 2020

Decision

60d

Days

Class 2

Risk

K202497 is an FDA 510(k) clearance for the Aulisa Multiple Patient Digital Vital Sign Monitoring System. This device is classified as a System, Network And Communication, Physiological Monitors (Class II - Special Controls, product code MSX).

Submitted by Taiwan Aulisa Medical Devices Technologies, Inc. (Taipei, TW). The FDA issued a Cleared decision on October 30, 2020, 60 days after receiving the submission on August 31, 2020.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K202497 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 31, 2020
Decision Date	October 30, 2020
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF