Identity
- Trade Name
- Steth IO FDA UDI
- Generic Name
- Electronic acoustic stethoscope FDA UDI
- Device Name
- Steth IO - The Smartphone Stethoscope for iPhone X FDA UDI
- Model / Reference
- iPhone X FDA UDI
- Description
- Steth IO - The Smartphone Stethoscope for iPhone X FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860135001934 FDA UDI
- 510(k) Number
- K160016 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
No
FDA UDI
MR Unsafe FDA UDI
Category: Electronic acoustic stethoscope
Steth IO by Steth IO — 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
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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
- Eko Core Electronic Stethoscope — Eko Devices, Inc. · Class II
Cleared under the same submission
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
- Steth IO
Sources (1)
- FDA UDI c3c169c1-f79e-4e02-9e0f-55d224f9757f 34 fields · synced May 30, 2026