FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
AViTA Pulse Oximeter
K Number: K223399
·
Decision May 20, 2024
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
27
Review Days
558
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Basic Information
- Device Name
- AViTA Pulse Oximeter
- K Number
- K223399
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Avita Corporation
- Date Received
- November 9, 2022
- Decision Date
- May 20, 2024
- Product Code
- DQA
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQA | Oximeter | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQA), ordered by most recent decision date.
Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)
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Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)
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Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
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AViTA Pulse Oximeter (SP61)
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YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Avita Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K250129 | AViTA Breast Pump | Jun 11, 2026 | Substantially Equivalent |
| K252448 | AViTA Pulse Oximeter (SP61) | Feb 27, 2026 | Substantially Equivalent |
| K250765 | AViTA Arm Type Blood Pressure Monitor Cuff | Sep 3, 2025 | Substantially Equivalent |
| K242455 | AViTA Pulse Oximeter (SP62B) | Feb 19, 2025 | Substantially Equivalent |
| K241852 | Nasal Aspirator (NS 13) | Dec 31, 2024 | Substantially Equivalent |
| K242193 | Arm Type Blood Pressure Monitor (BPM82) | Oct 22, 2024 | Substantially Equivalent |
| K200346 | Wrist Type Blood Pressure Monitor | Dec 17, 2020 | Substantially Equivalent |
| K180155 | Arm Type Blood Pressure Monitor | Aug 3, 2018 | Substantially Equivalent |
| K172427 | AViTA Radar Thermo NT16 Series IR Thermometer | Apr 19, 2018 | Substantially Equivalent |
| K112825 | AVITA ARM TYPE BLOOD PRESSURE MONITOR | Jan 18, 2012 | Substantially Equivalent |