FDA product code SIB: Tempo Pilot Eckm: Early Cardio-Kidney-Metabolic
SIB is the FDA product code for tempo pilot eckm: early cardio-kidney-metabolic. It is a Not classified device, reviewed by the Clinical Chemistry panel. Devices under SIB reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
TEMPO Pilot: early cardio-kidney-metabolic (hypertension, dyslipidemia, obesity or overweight with marker of central obesity, or prediabetes)
Classification
| Field | Value |
|---|---|
| Device name | Tempo Pilot Eckm: Early Cardio-Kidney-Metabolic |
| Device class | Not classified |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Recalls for SIB devices
openFDA lists no recalls for product code SIB.
Frequently asked questions
What is FDA product code SIB?
SIB is the FDA product code for tempo pilot eckm: early cardio-kidney-metabolic. It is a Not classified device, reviewed by the Clinical Chemistry panel.
What device class is SIB?
Not classified. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code SIB
- Run a recall and safety report across every SIB manufacturer
- Watch product code SIB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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