Product Code: SIC
FDA not classified
Tempo Pilot Ckm: Cardio-Kidney-Metabolic
Unknown
510(k)s
0
FEI Numbers
0
Registration Numbers
0
Unique Applicants
0
Years Active
—
Basic Information
- Product Code
- SIC
- Device Class
- FDA not classified
- Medical Specialty
- Unknown
- Review Panel
- CH
- Submission Type
- 7
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
TEMPO Pilot: cardio-kidney-metabolic (diabetes, chronic kidney disease, or atherosclerotic cardiovascular disease)
Unclassified Reason
6