Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- QLSPulse Oximeter For Low-Acuity Settings2Product Code
- PGJOximeter, Wellness2Product Code
- DPZOximeter, Ear2Product Code
- DQAOximeter2Product Code
- K242876Pulse Oximeter ( PO2, PO2A, PO2B)2Cleared 510(K)
- K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)2Cleared 510(K)
- K243086Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91)2Cleared 510(K)
- K242455AViTA Pulse Oximeter (SP62B)2Cleared 510(K)
- K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125)2Cleared 510(K)
- K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)2Cleared 510(K)
- K243049Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)2Cleared 510(K)
- K241090Evie Med Ring2Cleared 510(K)
- K232520Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH2Cleared 510(K)
- K240092Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504)2Cleared 510(K)
Show All 711 Submissions
- NLFOximeter, Reprocessed2Product Code
- OLKPulse Oximeter For Over-The-Counter Use2Product Code
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—MiscellaneousCFR Sub-Part
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Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K233963
- 510(k) Type
- Traditional
- Applicant
- Taiwan Aulisa Medical Devices Technologies, Inc.
- Country
- Taiwan
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/25/2025
- Days to Decision
- 438 days
- Submission Type
- Summary