FDA product code SIE: Tempo Pilot Bh: Behavioral Health
SIE is the FDA product code for tempo pilot bh: behavioral health. It is a Not classified device, reviewed by the Clinical Chemistry panel. Devices under SIE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
TEMPO Pilot: behavioral health (depression or anxiety)
Classification
| Field | Value |
|---|---|
| Device name | Tempo Pilot Bh: Behavioral Health |
| Device class | Not classified |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Recalls for SIE devices
openFDA lists no recalls for product code SIE.
Frequently asked questions
What is FDA product code SIE?
SIE is the FDA product code for tempo pilot bh: behavioral health. It is a Not classified device, reviewed by the Clinical Chemistry panel.
What device class is SIE?
Not classified. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code SIE
- Run a recall and safety report across every SIE manufacturer
- Watch product code SIE 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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