Identity
- Trade Name
- CORE 500 Digital Stethoscope - Black Bundle FDA UDI
- Generic Name
- Electronic acoustic stethoscope FDA UDI
- Device Name
- CORE 500 Digital Stethoscope - Black Bundle (Black CP and Black EP) FDA UDI
- Model / Reference
- E8 FDA UDI
- Description
- CORE 500 Digital Stethoscope - Black Bundle (Black CP and Black EP) FDA UDI
Identifiers
- Catalog Number
- COR501-BLK/BLK FDA UDI
- Primary DI / UDI-DI
- 00850010298290 FDA UDI
- 510(k) Number
- K233609 FDA UDI
- FDA Product Code
- DQD FDA UDIDPS FDA UDI
- GMDN Term
- Electronic acoustic stethoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1875 FDA UDI870.2340 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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Electronic acoustic stethoscope
CORE 500 Digital Stethoscope - Black Bundle by Eko Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Electronic acoustic stethoscope.
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Cleared under the same submission
K233609 also covers:
- CORE 500 Digital Stethoscope - Amethyst Bundle — Eko Devices, Inc.
- CORE 500 Digital Stethoscope - Bundle-BLK — Eko Devices, Inc.
- CORE 500 Digital Stethoscope - Bundle-CHP — Eko Devices, Inc.
- CORE 500 Digital Stethoscope - Bundle-SLV — Eko Devices, Inc.
- CORE 500 Digital Stethoscope - Champagne Bundle — Eko Devices, Inc.
- CORE 500 Digital Stethoscope - Incase Bundle — Eko Devices, Inc.
- CORE 500 Digital Stethoscope - Incase Bundle (Black) — Eko Devices, Inc.
- CORE 500 Digital Stethoscope - Sapphire Bundle — Eko Devices, Inc.
- CORE 500 Digital Stethoscope - Wintergreen Bundle — Eko Devices, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Eko Devices, Inc.
Sources (1)
- FDA UDI fd844fda-4012-410d-8680-497ebb20ee81 35 fields · synced May 30, 2026