FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PULSE OXIMETER
K Number: K102350
·
Decision Dec 22, 2010
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
50
Review Days
125
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Basic Information
- Device Name
- PULSE OXIMETER
- K Number
- K102350
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nonin Medical, Inc.
- Date Received
- August 19, 2010
- Decision Date
- December 22, 2010
- 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 Nonin Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K211498 | Nonin OTC Pulse Oximeter Model 3250 | Nov 13, 2024 | Substantially Equivalent |
| K192900 | H500 Multi-Sensing Oximetry System | Jun 29, 2020 | Substantially Equivalent |
| K191403 | Pulse Oximeter | Dec 20, 2019 | Substantially Equivalent |
| K190560 | SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface | May 2, 2019 | Substantially Equivalent |
| K172625 | Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor | May 11, 2018 | Substantially Equivalent |
| K160231 | Model X-100C CO-Met Oximetry System | Dec 23, 2016 | Substantially Equivalent |
| K160865 | Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso | Aug 5, 2016 | Substantially Equivalent |
| K151305 | SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg) | Aug 27, 2015 | Substantially Equivalent |
| K140785 | PULSE OXIMETER | Jul 7, 2014 | Substantially Equivalent |
| K132402 | SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM | Feb 21, 2014 | Substantially Equivalent |