Identity
- Trade Name
- E-Scope FDA UDI
- Generic Name
- Electronic acoustic stethoscope FDA UDI
- Device Name
- Clinical E-Scope FDA UDI
- Model / Reference
- 7187700 FDA UDI
- Description
- Clinical E-Scope FDA UDI
Identifiers
- Catalog Number
- 718-7700 FDA UDI
- Primary DI / UDI-DI
- B37571877000 FDA UDI
- 510(k) Number
- K961301 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electronic acoustic stethoscope
E-Scope by Cardionics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electronic acoustic stethoscope.
- TytoHome — TYTO CARE LTD · Class II
- 3M™ Littmann® — 3M COMPANY · 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
- Eko Core Electronic Stethoscope — Eko Devices, Inc. · Class II
- Steth IO Spot — Steth IO · Class II
Cleared under the same submission
K961301 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
- Cardionics, Inc.
Sources (1)
- FDA UDI e4e00cbc-7d3f-421d-8d21-51a80af07171 35 fields · synced May 30, 2026