K233963 is an FDA 510(k) clearance for the Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008). This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Taiwan Aulisa Medical Devices Technologies, Inc. (Taipei City, TW). The FDA issued a Cleared decision on February 25, 2025, 438 days after receiving the submission on December 15, 2023.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K233963 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2023 |
| Decision Date | February 25, 2025 |
| Days to Decision | 438 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA - Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |