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Sign in to claim this brandEchoNous
United States·US-MF-000004161
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 8310 154th Ave NE, Redmond, United States
- Website
- echonous.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Joshua Kim
- EUDAMED SRN
- US-MF-000004161
- FDA FEI Number
- 3013757696
- DUNS Number
- —
Catalogue (65)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Kosmos Hub | P006966 | EUDAMEDFDA UDI | Class I | Active |
| Kosmos Binaural Headset | P006115 | EUDAMEDFDA UDI | Class IIa | Active |
| Kosmos Torso | P006025 | EUDAMEDFDA UDI | Class IIa | Active |
| Kosmos Lexsa (Refurbished) | R006709 | EUDAMEDFDA UDI | Class IIa | Active |
| Kosmos Power Pack | P007640 | EUDAMEDFDA UDI | Class I | Active |
| Kosmos Bridge (Refurbished) | R006030 | EUDAMEDFDA UDI | Class IIa | Active |
| Kosmos OTS Android Doppler | P007701 | EUDAMEDFDA UDI | Class IIa | Active |
| Kosmos OTS Android Linear Color | P007465 | EUDAMEDFDA UDI | Class IIa | Active |
| Kosmos Power Pack (Refurbished) | R007640 | EUDAMEDFDA UDI | Class I | Active |
| Kosmos Torso-One – USB (Refurbished) | R006632 | EUDAMEDFDA UDI | Class IIa | Active |
| Kosmos Torso-One | P006440 | EUDAMEDFDA UDI | Class IIa | Active |
| Kosmos Torso-One (Refurbished) | R006440 | EUDAMEDFDA UDI | Class IIa | Active |
| Kosmos Software [Android] | P006576 | EUDAMEDFDA UDI | Class IIa | Active |
| Kosmos Lexsa | P006709 | EUDAMEDFDA UDI | Class IIa | Active |
| Kosmos Link | P008392 | EUDAMEDFDA UDI | Class I | Active |
Related Companies
Authorised Representatives
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Authorities
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FDA Recalls (1)
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 |
|---|---|---|---|---|
| May 9, 2024 | Z-2325-2024 | — | open, classified | Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd party software, such as PACS or other post-processing software, which may lead to inaccurate diagnoses or treatment. |