FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
SureTune4 Software
K Number: DEN210003
·
Decision Aug 23, 2021
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
2
Applicant Total
1
Review Days
201
Basic Information
- Device Name
- SureTune4 Software
- K Number
- DEN210003
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 882.5855
- Medical Specialty
- Neurology
- Decision
- Unknown
- Applicant
- Medtronic Neuromodulation
- Date Received
- February 3, 2021
- Decision Date
- August 23, 2021
- Product Code
- QQC
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| QQC | Brain Stimulation Programming Planning Software. | FDA class 2 | Neurology |
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