Identity
- Trade Name
- Cardiart Electronic Stethoscope FDA UDI
- Generic Name
- Electronic acoustic stethoscope FDA UDI
- Device Name
- The Electronic Stethoscope DS101 is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital. FDA UDI
- Model / Reference
- DS101 FDA UDI
- Description
- The Electronic Stethoscope DS101 is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719874400019 FDA UDI
- 510(k) Number
- K182196 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Electronic acoustic stethoscope
Cardiart Electronic Stethoscope by Imediplus 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
- 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
- Eko Core Electronic Stethoscope — Eko Devices, Inc. · Class II
Cleared under the same submission
K182196 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
- Imediplus Inc.
Sources (1)
- FDA UDI f5c8a059-6e68-413e-a993-248376f1fa6f 34 fields · synced May 29, 2026