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United States·US-MF-000030636
Last updated September 18, 2026
About
Sleep Testing: Easy. Affordable. Accurate. SleepImage Defies Convention SleepImage is a revolutionary approach to home sleep testing. Choose between hardware for multi-patient use and single-patient use to meet your needs. Whether you are looking for reducing cost or increasing efficiency, we have a solution for you, all backed by our FDA-cleared Software as a Medical…
From the manufacturer's own website. Source
Information
- Country
- United States
- Address
- 3200 E Cherry Creek Dr South , Denver, United States
- Website
- www.sleepimage.com
- —
- —
- [email protected]
- Phone
- +1 888 975 7464
- PRRC Contact
- Olivia Bustillos
- EUDAMED SRN
- US-MF-000030636
- FDA FEI Number
- —
- DUNS Number
- 964500776
Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SleepImage | 8 | FDA UDI | Class II | Unknown |
| SleepImage System | 2 | FDA UDI | Class II | Active |
| Cpc Sleep Data Recorder, Model M1, And Application Software | K092003 | FDA 510(k) | Class II | Active |
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