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Sign in to claim this brandCOMPUMEDICS USA, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 5015 West WT Harris Blvd, Suite E, Charlotte, NC, 28269
- Website
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3002716534
- DUNS Number
- —
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Siesta | Siesta 802 Basic PSG System | FDA UDI | Class II | Active |
| Siesta | Siesta 802 Basic EEG System | FDA UDI | Class II | Active |
| Compumedics Neuvo | K081151 | FDA 510(k) | Class II | Active |
| Compumedics Summit Ip | K040194 | FDA 510(k) | Class II | Active |
| Conductive Eeg Electrolyte | K033052 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
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Notified Bodies
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Authorities
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 24, 2005 | Z-0653-05 | — | terminated | Under specific conditions, the housing of the pulse oximeter contected to the amplifier can become excessively warm causing a burn upon contact with skin. |
| Feb 24, 2005 | Z-0652-05 | — | terminated | Under specific conditions, the housing of the pulse oximeter contected to the amplifier can become excessively warm causing a burn upon contact with skin. |