FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
Finger Type Pulse Oximeter
K Number: K151024
·
Decision Mar 2, 2016
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
123
Review Days
321
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Finger Type Pulse Oximeter
- K Number
- K151024
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Taidoc Technology Corporation
- Date Received
- April 16, 2015
- Decision Date
- March 2, 2016
- 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)
FDA 510(k)
FDA Class 2
·Cardiovascular
Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
FDA 510(k)
FDA Class 2
·Cardiovascular
Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)
FDA 510(k)
FDA Class 2
·Cardiovascular
Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
FDA 510(k)
FDA Class 2
·Cardiovascular
AViTA Pulse Oximeter (SP61)
FDA 510(k)
FDA Class 2
·Cardiovascular
YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Taidoc Technology Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K221349 | XPER Technology PREMIUM Pro Blood Glucose Monitoring System | Nov 19, 2024 | Substantially Equivalent |
| K201037 | FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System | Jun 16, 2022 | Substantially Equivalent |
| K200946 | Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241) | Apr 5, 2022 | Substantially Equivalent |
| K190579 | TD-4183 Blood Glucose Monitoring System | Jun 4, 2019 | Substantially Equivalent |
| K182934 | FORA P100 Blood Pressure Monitoring System | Feb 12, 2019 | Substantially Equivalent |
| K180863 | FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator | Dec 19, 2018 | Substantially Equivalent |
| K181675 | FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System | Dec 10, 2018 | Substantially Equivalent |
| K181588 | POPS! one Blood Glucose Monitoring System | Nov 30, 2018 | Substantially Equivalent |
| K172733 | TD-1035 Thermometer | Oct 22, 2018 | Substantially Equivalent |
| K173511 | ActiveCare TD-4121 Blood Glucose Monitoring System | Jul 12, 2018 | Substantially Equivalent |