Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)— 510(k) K233956

Substantially Equivalent

Taiwan Aulisa Medical Devices Technologies, Inc.

FDA 510(k) clearance K233956 for Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018), Substantially Equivalent on 2025-01-30. 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: 2023-12-15
Decision date: 2025-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, 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.