FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface
K Number: K190560
·
Decision May 2, 2019
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
73
Applicant Total
50
Review Days
58
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Basic Information
- Device Name
- SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface
- K Number
- K190560
- 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
- March 5, 2019
- Decision Date
- May 2, 2019
- Product Code
- MUD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| MUD | Oximeter, Tissue Saturation | FDA class 2 | Cardiovascular |
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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 |
| 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 |
| K131021 | PULSE OXIMETER | Sep 11, 2013 | Substantially Equivalent |