K233956
- 510(k) number
- K233956
- Device name
- Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)
- Applicant
- Taiwan Aulisa Medical Devices Technologies, Inc. TW
- Product code
- DQA — Oximeter
- Decision date
- 2025-01-30
- Date received
- 2023-12-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K233956.pdf
Official FDA record: K233956
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.