Identity
- Trade Name
- Eko Core Attachment FDA UDI
- Generic Name
- Electronic acoustic stethoscope FDA UDI
- Device Name
- The Eko Core Attachment connects to (and digitizes) the analog stethoscope you already own. It attaches to almost all single-tubed stethoscopes including LittmannTM, Welch AllynTM, MDFTM, and ADCTM. The Eko Core Attachment wirelessly pairs to the free Eko mobile app for recording, visualization, sharing, and annotation of sounds. FDA UDI
- Model / Reference
- Model E4 FDA UDI
- Description
- The Eko Core Attachment connects to (and digitizes) the analog stethoscope you already own. It attaches to almost all single-tubed stethoscopes including LittmannTM, Welch AllynTM, MDFTM, and ADCTM. The Eko Core Attachment wirelessly pairs to the free Eko mobile app for recording, visualization, sharing, and annotation of sounds. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00863609000310 FDA UDI
- 510(k) Number
- K151319 FDA UDI
- FDA Product Code
- DQD FDA UDI
- GMDN Term
- Electronic acoustic stethoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1875 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electronic acoustic stethoscope
Eko Core Attachment by Eko Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electronic acoustic stethoscope.
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- E-Scope — Cardionics, Inc. · Class II
- Adscope® — American Diagnostic Corporation · Class II
- TytoHome — TYTO CARE LTD · Class II
- Adscope® — American Diagnostic Corporation · Class II
- RNK Products — Rnk Products, Inc. · Class II
- Steth IO Spot — Steth IO · Class II
Cleared under the same submission
K151319 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Eko Devices, Inc.
Sources (1)
- FDA UDI 14f0252c-57f8-4790-92e4-6d62e2c07083 34 fields · synced May 30, 2026