Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System— 510(k) K191207

Substantially Equivalent

Taiwan Aulisa Medical Devices Technologies, Inc.

FDA 510(k) clearance K191207 for Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System, Substantially Equivalent on 2019-06-25. Applicant: Taiwan Aulisa Medical Devices Technologies, Inc..

Clearance details

Applicant: Taiwan Aulisa Medical Devices Technologies, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2019-05-06
Decision date: 2019-06-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.