Steth IO Spot

FDA UDI

Class II (US FDA UDI)

by Steth IO

Identity

Trade Name: Steth IO Spot FDA UDI
Generic Name: Electronic acoustic stethoscope FDA UDI
Device Name: The Steth IO Spot is an acoustic device with an integrated microphone that collects biological sounds. Steth IO Spot attaches to the lightning port/USB-Type C (Universal Serial Bus Type C) port of the smartphone and can be utilized to auscultate patients during physical examination. The sound is then analyzed by the Steth IO Spot software telemedicine application (app) installed on the smartphone. This analysis enables a healthcare provider to identify sounds and from targeted areas of interest that may be present. A web portal (i.e., the Steth IO Portal) may also be used to access recorded patient data and to hold telemedicine calls. FDA UDI
Model / Reference: 1.0 FDA UDI
Description: The Steth IO Spot is an acoustic device with an integrated microphone that collects biological sounds. Steth IO Spot attaches to the lightning port/USB-Type C (Universal Serial Bus Type C) port of the smartphone and can be utilized to auscultate patients during physical examination. The sound is then analyzed by the Steth IO Spot software telemedicine application (app) installed on the smartphone. This analysis enables a healthcare provider to identify sounds and from targeted areas of interest that may be present. A web portal (i.e., the Steth IO Portal) may also be used to access recorded patient data and to hold telemedicine calls. FDA UDI

Identifiers

Primary DI / UDI-DI: 00860135001958 FDA UDI
510(k) Number: K220196 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Electronic acoustic stethoscope

Steth IO Spot by Steth IO — 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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Eko Core Electronic Stethoscope — Eko Devices, Inc. · Class II

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 4a85b648-b56e-42c5-ab70-ddee03a67699 35 fields · synced Jun 8, 2026